# US 11,484,718 B2 · Multimode ICD system comprising phased array amplifiers to treat and manage CRT, CHF, and PVC disorders using ventricle level-shifting therapy to minimize VT/VF and SCA

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- Number: US 11,484,718 B2
- Document ID: US11484718B2
- Status: Granted
- Kind: B2
- Application number: 17/582,702
- Filed: 2022-01-24
- Published: 2022-07-28
- Granted: 2022-11-01
- Earliest claimed: 2021-01-22
- Assignees: Ruse Technologies, LLC
- Applicants: Ruse Technologies, LLC
- Inventors: Richard B. Ruse; Charles Swerdlow; Mark W. Kroll; Scott Bohanan
- Web page: https://patentgrep.com/patent/US11484718B2

## CPC

- A61N 1/36585: {controlled by two or more physical parameters}
- A61N 1/0563: {specially adapted for defibrillation or cardioversion}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/36542: {controlled by body motion, e.g. acceleration}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- A61N 1/39622: {Pacing 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)

## Abstract

An ICD multimode system comprises a microcontroller or FPGA having a memory, a differentially driven phased array amplifier, one or more sensors, and a wireless transmitter/receiver. Based upon sensor data and demand criteria programmed into the memory, the system provides late systolic impulse (LSI) therapy to treat congestive heart failure (CHF) and ventricle level-shifting (VLS) therapy to block unwanted PVCs to prevent VT or VF dynamically and use a phased array amplifier therapy to accurately manage CRT. An external echocardiogram and ultrasound system adjusts the therapies administered based upon sensor and demand data in real time to allow a patient's heart to function at a level of improved performance and increase ejection fraction EF.

## Claims

### Claim 1

An implantable cardioverter defibrillator (ICD) system for administering cardiac therapy to a patient, which comprises:
a subcutaneous case capable of being positioned under a patient's skin and in communication with the patient's heart;
an arbitrary waveform control system located within the subcutaneous case, the arbitrary waveform control system comprising:
a microcontroller or FPGA having a memory;
differentially driven phased array amplifiers comprising hot can amplifier A1 and amplifiers A2, A3, and A4;
a wireless transmitter/receiver; and
a battery;
one or more sensors;
a bipolar pacing lead to be positioned in a right ventricle (RV) of the patient's heart and in functional communication with amplifier A4;
a right ventricular (RV) pacing and shocking coil/defibrillation lead in functional communication with amplifier A2; and
a left ventricular (LV) and/or coronary sinus (CS) pacing lead in functional communication with amplifier A3,
wherein the bipolar pacing lead, amplifier A4, the right ventricular (RV) pacing and shocking coil/defibrillation lead, amplifier A2, the left ventricular (LV) and/or coronary sinus (CS) pacing lead, and amplifier A3 form a triangular electrical field, and
wherein, based upon sensor data and demand criteria software programmed into the memory of the microcontroller or FPGA, the bipolar pacing lead, the right ventricular pacing and shocking coil/defibrillation lead, and the left ventricular and/or coronary sinus pacing lead deliver cardiac therapy to the patient's heart.

### Claim 2 (depends on 1)

The system of claim 1, wherein the differentially driven phased array amplifier circuits deliver constant voltage or constant current ascending arbitrary ramp or curved waveforms, BTE waveforms, for defibrillation, or cardioversion electrical shocks to the patient's heart which are capable of being driven to deliver medically useful, dynamically steered current vectors to the patient's heart using any voltage and/or arbitrary ramp or curved waveforms for a medically useful cardiac therapy.

### Claim 3 (depends on 1)

The system of claim 1, wherein the sensors are selected from the group consisting of an O2 sensor, an ECG, an inclinometer, and an accelerometer, which provide feedback to the microcontroller or FPGA.

### Claim 4 (depends on 1)

The system of claim 1, wherein the cardiac therapy is delivered using the same phased array amplifiers and is commanded by software algorithms within the memory to pace, cardiovert, defibrillate, or deliver late systolic impulses (LSI) to the ventricles for the treatment of congestive heart failure (CHF) to increase ejection fraction (EF) by increasing the force of LV/RV contractions, during the absolute refractory period within the QRS complex, based on data from one or more sensors that are translated into commands to deliver therapies.

### Claim 5 (depends on 1)

The system of claim 1, wherein ventricle level shifting (VLS) software in the microcontroller or FPGA and hardware within the ICD system that delivers an atraumatic, sub-threshold, tonic negative bias voltage during vulnerable periods between QRS complexes that blocks or inhibits premature ventricular contractions (PVCs) from triggering ventricular tachycardia (VT)/ventricular fibrillation (VF) that may cause sudden cardiac arrest (SCA).

### Claim 6 (depends on 1)

The system of claim 1 which comprises an implanted internal magnetic power supply that uses body motion to assist charging the battery and/or delivers voltage and current on demand as required by the ICD system.

### Claim 7 (depends on 1)

The system of claim 1, wherein in a cardiac resynchronization therapy (CRT) mode the phased array amplifiers are phase shifted differentially to deliverer accurate CRT pulses that properly synchronize a right ventricle (RV) and a left ventricle (LV) with regard to time difference between force contractions of the two ventricles to maximize the ejection fraction (EF) wherein the phased array amplifiers deliver software commanded, electronically regulated voltage and current arbitrary pulses of any shape and amplitude from stored energy available to deliver accurate CRT therapy as well as to deliver LSI for CHF in which the combined therapies of CHF and CRT increase EF to benefit the patient.

### Claim 8 (depends on 1)

The system of claim 1, wherein in a congestive heart failure (CHF)/late systolic impulse (LSI) mode late systolic impulses are provided during the absolute refractory period of the QRS complexes which are delivered through the RV and LV for the purpose of increasing the ventricle contraction forces, which then increase the ejection fraction (EF) within the patient's heart.

### Claim 9 (depends on 1)

The system of claim 1, wherein in a ventricle level shifting (VLS) mode a negative low voltage, low current, steerable, atraumatic sub-threshold electrical field or tonic, negative electrical therapy is delivered that level shifts cells of the ventricles from a normal resting voltage of about −90 mV as referenced to the isoelectric line or zero voltage base line ECG to a more negative voltage from about −100 mV to about −300 mV to prevent and/or block premature ventricular contractions (PVCs) during vulnerable time periods during a T wave interval that may induce VT/VF or SCA.

### Claim 10 (depends on 9)

The system of claim 9, wherein the negative voltages may be DC voltages or pulsed or stepped voltages using arbitrary waveforms to deliver the negative voltage ventricle level shifting (VLS) therapies.

### Claim 11 (depends on 1)

The system of claim 1, wherein the waveform energy control system further comprises a hot can (HC) that provides an amplifier A1 as a vector steering surface and wherein the phased array amplifiers comprise three amplifiers A2, A3, and A4 that provide current paths between each other and the hot can (HC) amplifier A1 to deliver cardiac therapy through the entire syncytium of the ventricles whereby the same four amplifiers may deliver therapies at different time periods that treat several different conditions.

### Claim 12 (depends on 1)

The system of claim 1, wherein an inclinometer and/or an accelerometer indicates that there is a posture and/or activity change in real time which induces an automatic adjustment of the LSI impulses to treat CHF which increases the ejection fraction (EF) percentage, and physiological changes within the ECG are adjusted for situations that require electrical correction to improve cardiac output efficiency.

### Claim 13 (depends on 1)

A method of treating a cardiac condition in a patient, which comprises implanting an implantable cardiac system of claim 1 into the patient and delivering appropriate treatments to the patient.

### Claim 14 (depends on 13)

The method of claim 13, wherein the cardiac condition treated is R on T phenomenon, Long QT Syndrome, congestive heart failure (CHF), low EF, ventricular tachycardia (VT), ventricular fibrillation (VF), Brugada Syndrome, any other idiopathic or genetically aberrant disorder that induces an unacceptable number of PVCs per minute that induces potentially serious or fatal arrythmias, or a benign ventricular disorder.

### Claim 15 (depends on 13)

The method of claim 13, wherein the appropriate treatment is ventricle level shifting (VLS) therapy which uses premature ventricular contractions (PVC) blocking therapy, anti-tachycardia pacing (ATP) therapy, congestive heart failure (CHF) therapy which uses late systolic impulse (LSI) therapy, and cardiac resynchronization therapy (CRT) using a triangular electrical field that includes the shocking coil, or low voltage/medium voltage (LV/MV) therapy using arbitrary waveform therapy, to treat pulseless electrical activity (PEA) and/or asystole rescue.

### Claim 16 (depends on 13)

The method of claim 13, wherein the benign ventricular disorder is irretractable ventricular bigeminy, trigeminy, or another idiopathic cause of excessive PVCs or VT or VF that effects the patient's well-being.

### Claim 17 (depends on 13)

The method of claim 13, wherein VLS therapy comprises delivering a subthreshold, atraumatic, negative, tonic voltage stimulus to a left ventricle (LV) and/or coronary sinus (CS) from an amplifier A3 lead to deliver voltage stimulus between an amplifier A4 in the right ventricle (RV) of a patient's heart and to also deliver further negative voltage between a shocking coil amplifier A2 to create a triangular electrical field whereby PVCs can be dynamically blocked within the intraventricular septum at the heart's apex to block and prevent PVCs which cause VF during the vulnerable period during a T wave or vulnerable period as defined herein causing a steerable conduction block that prevents PVCs from conducting from the upper intraventricular septum outflow tracts that conduct downward to the apex which are the pathways for PVCs to induce VF in the case of Brugada Syndrome or any other PVC triggered episode of VF which leads to SCA.

### Claim 18 (depends on 13)

The method of claim 13, wherein delivering the VLS therapy during an episode of ventricular fibrillation using amplifiers A1, A2, A3, and A4 closes the sodium channels throughout the entire syncytium of the ventricles using multiple negative wavefronts and/or negative pulses whether pulsed or stepped to effectively defibrillate the ventricles.

### Claim 19 (depends on 1)

The system of claim 1, wherein a single implantable cardiac device is capable of treating and managing several distinct cardiac disorders selected from the group consisting of VT/VF arbitrary waveform defibrillation, PVCs, CRT, CHF, PEA, Brugada Syndrome, R on T Phenomenon, Long QT Syndrome, Chronic ventricular bigeminy, trigeminy, Bradycardia, and shockless defibrillation and/or ascending ramp, arbitrary, or BTE high voltage shocking waveforms.

### Claim 20

An implantable cardioverter defibrillator (ICD) system for administering cardiac therapy to a patient, which comprises:
a subcutaneous case capable of being positioned under a patient's skin and in communication with the patient's heart;
an arbitrary waveform control system located within the subcutaneous case, the arbitrary waveform control system comprising:
a microcontroller or FPGA having a memory; and
differentially driven phased array amplifiers comprising hot can amplifier A1 and amplifiers A2, A3, and A4; and
a battery;
one or more sensors;
a bipolar pacing lead to be positioned in a right ventricle (RV) of the patient's heart and in functional communication with amplifier A4;
a right ventricular (RV) pacing and shocking coil/defibrillation lead in functional communication with amplifier A2; and
a left ventricular (LV) and/or coronary sinus (CS) pacing lead in functional communication with amplifier A3,
wherein the bipolar pacing lead, amplifier A4, the right ventricular (RV) pacing and shocking coil/defibrillation lead, amplifier A2, the left ventricular (LV) and/or coronary sinus (CS) pacing lead, and amplifier A3 form a triangular electrical field, and
wherein, based upon sensor data and demand criteria software programmed into the memory of the microcontroller or FPGA, the bipolar pacing lead, the right ventricular pacing and shocking coil/defibrillation lead, and the left ventricular and/or coronary sinus pacing lead deliver cardiac therapy to the patient's heart.

### Claim 21 (depends on 20)

A method of treating a cardiac condition in a patient, which comprises implanting an implantable cardiac system of claim 20 into the patient and administering appropriate treatment to the patient.