# US 8,784,292 B2 · Double balloon pump cardiac assist device and related method of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,292 B2 - Document ID: US8784292B2 - Status: Granted - Kind: B2 - Application number: 13/550,555 - Filed: 2012-07-16 - Published: 2013-07-18 - Granted: 2014-07-22 - Earliest claimed: 2006-04-24 - Applicants: Yoel Ovil; Yotam Ovil; Ace Ovil - Inventors: Yoel Ovil; Yotam Ovil; Ace Ovil - Web page: https://patentgrep.com/patent/US8784292B2 ## CPC - A61N 1/36592: {controlled by the heart rate variability} - A61M 60/139: inside the aorta, e.g. intra-aortic balloon pumps - A61M 60/17: inside a ventricle, e.g. intraventricular balloon pumps - A61M 60/295: Balloon pumps for circulatory assistance - A61M 60/497: for balloon pumps for circulatory assistance - A61M 60/515: Regulation using real-time patient data - A61M 60/569: synchronous with the native heart beat - A61M 60/843: Balloon aspects, e.g. shapes or materials - A61N 1/362: Heart stimulators (heart defibrillators A61N1/39) - A61N 1/056: {Transvascular endocardial electrode systems} - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A system and method for cardiac assist of a heart in a beating stage comprising a double balloon catheter having a proximal end and a distal end, the catheter having at least one lumen; an inflatable intra-ventricular balloon mounted on the catheter near the distal end of the catheter, the balloon having a lumen in fluid communication with the lumen of the catheter and being configured for inflation in a ventricle; and an intra-aortic balloon mounted on the catheter proximally to the intra-ventricular balloon; a control unit comprising a bidirectional pump; a fluid reservoir; and a processor configured to activate the pump; wherein the proximal end of the catheter is configured for attachment to the control unit to form a fluid conduction system in which fluid is configured to be pumped by the pump between the fluid reservoir and the intra-ventricular balloon and the intra-aortic balloon; and systolic augmentation comprising a new pressure wave which is generated when said balloon is inflated at the end of the slow ejection phase of the beating heart, such that any residual volume of blood left in said ventricle is displaced. ## Claims ### Claim 1 A system for cardiac assist of a heart in a beating stage comprising: (a) a double balloon catheter having a proximal end and a distal end, the catheter having at least one lumen; (b) an inflatable intra-ventricular balloon mounted on the catheter near the distal end of the catheter, the balloon having a lumen in fluid communication with the lumen of the catheter and being configured for inflation in a ventricle; and (c) an intra-aortic balloon mounted on the catheter proximally to the intra-ventricular balloon; (d) a control unit comprising: (1) a bidirectional pump; (2) a fluid reservoir; and (3) a processor configured to activate the pump; wherein the proximal end of the catheter is configured for attachment to the control unit to form a fluid conduction system in which fluid is configured to be pumped by the pump between the fluid reservoir and the intra-ventricular balloon and the intra-aortic balloon; (e) at least one or more electrodes mounted on the catheter near the distal end generating a signal indicative of electrical activity of the heart and wherein the processor is configured to receive the electrical signals to operate the pump to coordinate inflation and deflation of the balloons with the cardiac cycle; wherein the control unit is configured to begin inflating the intraventricular balloon at the end of the slow ejection phase of the beating heart, before closure of either the aortic valve or pulmonic valve in the right ventricle, such that a new pressure wave is created to generate systolic augmentation, and any residual volume of blood left in said ventricle is displaced to achieve a pre-determined intra-ventricular systolic pressure. ### Claim 2 (depends on 1) The system according to claim 1, wherein said slow ejection phase corresponds to the ascending part of the ECG-T wave of the beating heart. ### Claim 3 (depends on 1) The system according to claim 1, wherein said double balloon pump catheter is configured to be introduced into the left ventricle through the femoral artery or into the aorta through a left mini non-invasive thoraectomy. ### Claim 4 (depends on 1) The system according to claim 1, wherein the proximal part of said electrodes are connected to a pacemaker box. ### Claim 5 (depends on 1) The system according to claim 1, wherein the processor is configured to analyze the signal indicative of electrical activity and to identify in the signal one or more phases of the electrical activity of the cardiac cycle. ### Claim 6 (depends on 1) The system according to claim 1, wherein the processor is configured to drive the electrodes to pace the heart. ### Claim 7 (depends on 6) The system according to claim 6 wherein the processor is configured to activate the pump to inflate the intra-ventricular balloon during a predetermined first phase of the cardiac cycle. ### Claim 8 (depends on 7) The system according to claim 7 wherein the predetermined first phase is the end of the slow ejection phase corresponding to the ascending part of the T wave. ### Claim 9 (depends on 5) The system according to claim 5 wherein the processor is configured to activate the pump to deflate the intra-ventricular balloon during a predetermined second phase of the cardiac cycle. ### Claim 10 (depends on 9) The system according to claim 9 wherein the predetermined second phase begins at the peak of systolic augmentation corresponding to the descending part of the T-wave. ### Claim 11 (depends on 1) The system according to claim 1 further comprising a pressure transducer mounted on the catheter near the distal end configured to generating a signal indicative of intra-ventricular blood pressure wherein the processor is configured to receive blood pressure signals. ### Claim 12 (depends on 11) The system according to claim 11 wherein the processor is configured to activate the pump to deliver a volume of the fluid to the intra-ventricular balloon to achieve a predetermined intra-ventricular systolic blood pressure. ### Claim 13 (depends on 11) The system according to claim 11 further comprising a bladder within said control unit which functions as a fluid reservoir, wherein the processor is configured to activate the pump to deliver a volume of the fluid from the intra-ventricular balloon to the bladder. ### Claim 14 (depends on 9) The system according to claim 9 wherein the processor is configured to activate the pump to inflate the intra-aortic balloon during a predetermined third phase of the cardiac cycle. ### Claim 15 (depends on 14) The system according to claim 14 wherein the predetermined third phase of the cardiac cycle is the end of the T wave. ### Claim 16 (depends on 14) The system according to claim 14 wherein the processor is configured to activate the pump to deflate the intra-aortic balloon during a predetermined fourth phase of the cardiac cycle. ### Claim 17 (depends on 16) The system according to claim 16 wherein the predetermined fourth phase of the cardiac cycle is the beginning of the P-wave of the subsequent cycle. ### Claim 18 A method for cardiac assist of a heart in a beating stage comprising: (a) Providing a double balloon catheter having a proximal end and a distal end, the catheter having at least one lumen; and an inflatable balloon mounted on the catheter near the distal end of the catheter, the balloon having a lumen in fluid communication with the lumen of the catheter and being configured for inflation in a ventricle; (b) Delivering a first balloon to a ventricle of the heart; (c) Delivering the second balloon into the aorta; (d) During one or more cardiac cycles, transiently inflating the first balloon to achieve systolic augmentation comprising a new pressure wave which is generated when beginning inflation of said first balloon at the end of the slow ejection phase of the beating heart, and (e) inflating the second balloon from the beginning of the diastolic phase and deflating at the end of the diastolic phase, such that any residual volume of blood left in said ventricle is displaced. ### Claim 19 (depends on 18) The method according to claim 18, wherein said slow ejection phase corresponds to the ascending part of the ECG-T wave of the beating heart. ### Claim 20 (depends on 18) The method according to claim 18, wherein the catheter further comprises one or more electrodes mounted on the catheter near the distal end, and the method further comprises generating a signal indicative of electrical activity of the heart. ### Claim 21 (depends on 20) The method according to claim 20, further comprising driving the electrodes to pace the heart. ### Claim 22 (depends on 20) The method according to claim 20, further comprising analyzing the signal indicative of electrical activity and identifying in the signal one or more phases of the electrical activity of the cardiac cycle. ### Claim 23 (depends on 22) The method according to claim 22, further comprising inflating the first balloon during a predetermined first phase of the cardiac cycle. ### Claim 24 (depends on 23) The method according to claim 23, wherein the predetermined first phase is the end of the slow ejection phase corresponding to the ascending part of the T wave. ### Claim 25 (depends on 22) The method according to claim 22, further comprising deflating the first balloon during a predetermined second phase of the cardiac cycle. ### Claim 26 (depends on 25) The method according to claim 25, wherein the predetermined second phase is the peak of the T-wave corresponding to the peak of systolic augmentation and deflation of the first balloon is completed at the end of the T-wave corresponding to the dicrotic notch. ### Claim 27 (depends on 18) The method according to claim 18, wherein the catheter further comprises a pressure transducer mounted on the catheter near the distal end the method further comprises generating a signal indicative of intra-ventricular blood pressure. ### Claim 28 (depends on 27) The method according to claim 27 further comprising delivering a volume of the fluid to the first balloon to achieve a predetermined intra-ventricular systolic blood pressure. ### Claim 29 (depends on 28) The method according to claim 28 further comprising deflating the first balloon to achieve a predetermined intra-ventricular diastolic blood pressure. ### Claim 30 (depends on 18) The method according to claim 18, wherein the ventricle is a left ventricle. ### Claim 31 (depends on 18) The method according to claim 18, further comprising providing a portable rechargeable pump for use in ventricular failure.