Abstract:
A balloon is positionable in the patient&#39;s descending aorta. The balloon includes a balloon catheter and two pressure sensors that electrically couple to an extra-corporeal controller. The balloon itself also couples pneumatically to the extra-corporeal controller. An extra-corporeal pump electrically couples to the extra-corporeal controller, the pump having an outlet connectable to the patient&#39;s infra-diaphragmatic artery. The pump inlet is connectable via a cannula to the patient&#39;s supra-diaphragmatic artery.  
     A doctor inserts the balloon into the descending aorta, and positions the balloon near the level of the patient&#39;s diaphragm. A balloon catheter, coupled to the extra-corporeal controller, inflates and deflates the balloon. An electrocardiogram ECG and proximal aortic blood pressure, measured in the upper arterial compartment via a lumen in the balloon catheter, serve as inputs to cycle the balloon synchronously with the heartbeat.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a divisional of application Ser. No. 10/106,744, filed Mar. 26, 2002, and is hereby incorporated herein by reference. 
     
    
     
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
         [0002]    Not Applicable.  
         REFERENCE TO A “SEQUENTIAL LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISC  
         [0003]    Not Applicable.  
         BACKGROUND OF THE INVENTION  
         [0004]    Many types of cardiac assist devices have been developed over the past 40 years. The general types of devices can be characterized as short-term (hours to days), bridge-to-transplantation, bridge-to-recovery, and permanent or long-term. The goal of these devices is to mechanically support the failing heart by increasing systemic perfusion, and/or reducing the workload of the failing heart, thus creating the most favorable environment for cardiac recovery.  
           [0005]    Short-term devices are used on patients whose hearts have sustained a serious injury but can recover if adequately supported. The most commonly used short-term device is the intra-aortic balloon pump (“IABP”). Indications for employment of the IABP include cardiogenic shock or severe heart failure secondary to acute myocardial infarction or following open-heart surgery, unstable angina resistant to drug therapy, and refractory ventricular irritability after myocardial infarction. *  
           [0006]    The basic components of the intra-aortic balloon pump (“IABP”) are a catheter tipped with a long balloon and a pump console that shuttles helium gas through the catheter to inflate and deflate the balloon synchronously with the heart beat. The balloon is inserted into an artery and guided to a position in the descending thoracic aorta just distal to the left subclavian artery. The pump control console contains signal processing, drive, timing, and control mechanisms for appropriate inflation and deflation. During cardiac systole ventricular contraction and ejection, the IABP is rapidly deflated, reducing the workload and oxygen demands of the heart by decreasing the resistance to blood flow from the ventricle. During cardiac diastole ventricular relaxation and filling, the IABP is rapidly inflated counter-pulsation increasing aortic and coronary perfusion pressures. Timing of the inflation-deflation cycle is based on the electrocardiogram and arterial blood pressure waveform.  
           [0007]    When heart failure is severe, the IABP cannot provide adequate circulatory support because it cannot replace cardiac function. The treatment of severe heart failure requires the use of cardiac-bypass blood pumps. These devices are more invasive than the IABP and employ direct cannulation of the ventricle or atrium. Implantation and removal of the cardiac cannulas may further injure the heart and be associated with bleeding complications. It is estimated that nearly 100,000 patients worldwide underwent short-term mechanical circulatory support during 2000.  
           [0008]    Because of the limitations of aortic bypass pumps, intra-aortic balloon pumps, and the complications associated with cardiac bypass pumps, there is a need for an improved short-term heart-assist device.  
         FIELD OF THE INVENTION  
         [0009]    The present invention relates generally to methods and devices for mechanically assisting the failing heart. More specifically, it relates to balloon catheters and bypass pumps.  
         DESCRIPTION OF RELATED ART  
         [0010]    The related art can be reviewed by the following patents. The full disclosures of the following patents are incorporated herein by this reference:  
           [0011]    The following patents disclose intra-aortic balloon pumps. The full disclosures of these patents are all incorporated herein by this reference:  
                                       6,290,641   Intra-aortic balloon pump having improved automated           electrocardiogram based intra-aortic balloon deflation timing       6,245,008   Fast response intra-aortic balloon pump       6,241,706   Fast response intra-aortic balloon pump       6,238,382   Intra-aortic balloon catheter having a tapered Y-fitting       6,210,319   Intra-aortic balloon pump condensation prevention system       6,191,111   Method and device for enhancing of biobypass by increasing           the coronary blood flow       5,817,001   Method and apparatus for driving an intra-aortic balloon pump                  
 
           [0012]    The following patents disclose intra-aortic balloons. The full disclosures of these patents are all incorporated herein by this reference:  
                                       6,213,975   Intra-aortic balloon catheter having an ultra-thin stretch blow           molded balloon membrane       6,149,578   Piston-action intra-aortic coronary assist device       6,024,693   Intra-aortic balloon catheter       5,935,501   Method for making a packaging sheath for intra-aortic balloon           catheters       5,928,132   Closed chest intra-aortic balloon based ventricular assist           device       5,913,814   Method and apparatus for deflation of an intra-aortic balloon       5,865,721   Intra-aortic balloon catheters       5,817,001   Method and apparatus for driving an intra-aortic balloon pump       5,772,631   Procedure for alleviating arterial obstruction       5,759,175   Intra-aortic balloon catheter       5,718,861   Method of forming intra-aortic balloon catheters       5,697,906   Intra-aortic balloon catheter       5,683,347   Balloon catheter       5,618,270   Transthoracic aortic sleeve       5,599,329   Multi purpose perfusion cannula       5,524,757   Packaging sheaths for intra-aortic balloon catheters       5,460,607   Balloon catheter       5,456,665   Intra-aortic balloon catheter       RE34,993   Method of inserting a lab device into the body       5,413,549   Devices and methods for efficient intra-aortic balloon           pumping       5,330,451   Multi purpose perfusion cannula       5,230,692   Intra-aortic balloon pump       5,158,529   Pumping device for operating an intra-aortic balloon       5,120,299   Intra-aortic balloon assembly with hemostasis device       4,994,018   Intra-aortic balloon assembly       4,901,707   Prepackaged intra-aortic balloon assembly with holder, and           method of using same       4,897,077   Method of inserting an IAB device into the body       4,827,906   Apparatus and method for activating a pump in response to           optical signals from a pacemaker       4,809,681   Electrocardiographic measurement method for controlling an           intra-aortic balloon pump       4,804,358   Coronary perfusion pump       4,733,652   Intra-aortic balloon       4,697,573   Percutaneous intra-aortic balloon and method for using same       4,644,936   Percutaneous intra-aortic balloon and method for using same       4,576,142   Percutaneous intra-aortic balloon and method for using same       4,552,127   Percutaneous intra-aortic balloon having an EKG electrode           and a twisting stylet for coupling the EKG electrode to           monitoring and/or pacing instrumentation external to the body       4,531,512   Wrapping system for intra-aortic balloon utilizing a wrapping           envelope       4,522,195   Apparatus for left heart assist       4,522,194   Method and an apparatus for intra-aortic balloon monitoring           and leak detection       4,515,587   IAB having apparatus for assuring proper balloon inflation           and deflation       4,473,067   Introducer assembly for intra-aortic balloons and the like           incorporating a sliding, blood-tight seal       4,467,790   Percutaneous balloon       4,444,186   Envelope wrapping system for intra-aortic balloon       4,422,447   Percutaneous balloon       4,407,271   Apparatus for left heart assist       4,402,307   Balloon catheter with rotatable energy storing support member       4,362,150   Percutaneous intra-aortic balloon apparatus       4,346,698   Balloon catheter with rotatable support       4,327,709   Apparatus and method for the percutaneous introduction of           intra-aortic balloons into the human body       4,311,133   Intra-aortic balloon       4,287,892   Cannula for intra-aortic balloon devices and the like       4,276,874   Elongatable balloon catheter       4,261,339   Balloon catheter with rotatable support       4,122,858   Adapter for intra-aortic balloons and the like       4,080,958   Apparatus for aiding and improving the blood flow in patients       3,985,123   Method and means for monitoring cardiac output                  
 
           [0013]    Aortic occlusion balloons are known in the prior art. Such aortic balloons are non co-pulsating with the heartbeat and are not employed with an aortic bypass pump. The following patents disclose aortic occlusion balloons. The full disclosures of these patents are all incorporated herein by this reference:  
                                       6,254,563   Perfusion shunt apparatus and method       6,248,086   Method for cannulating a patient&#39;s aortic arch and occluding           the patients ascending aortic arch       5,413,558   Selective aortic perfusion system for use during CPR       5,216,032   Selective aortic arch perfusion using perfluorochemical and           alpha-adrenergic agonist to treat cardiac arrest       5,195,942   Cardiac arrest treatment       4,697,574   Pump for assistance in circulation       4,531,936   Device and method for the selective delivery of drugs to the           myocardium                  
 
           [0014]    The following patents disclose cardiac bypass pumps. The full disclosures of these patents are all incorporated herein by this reference:  
                                       6,238,334   Method and apparatus for assisting a heart to pump blood       6,149,683   Power system for an implantable heart pump       6,099,460   Electromagnetic head-assist technique and apparatus       6,015,434   Artificial heart pump       5,588,812   Implantable electric axial-flow blood pump       5,443,503   Artificial heart pump       5,344,443   Heart pump                  
 
           [0015]    Aortic bypass pumps are known in the prior art. Aortic bypass pumps are not employed with a co-pulsating aortic occlusion balloon for heart assistance. The following patents disclose aortic bypass pumps. The full disclosures of these patents are all incorporated herein by this reference:  
                                                       6,299,575   Implantable heart assist system           6,200,260   Implantable heart assist system           5,749,855   Catheter pump           4,968,293   Circulatory assist device                      
 
         BRIEF SUMMARY OF THE INVENTION  
         [0016]    A preferred embodiment of the present invention provides a method and a system to temporarily assist the failing heart. The temporary heart-assist system comprises an occluding device positionable in the patient&#39;s descending aorta. The occluding device may or may not include a pressure sensor that electrically couples to an extra-corporeal controller. The occluding device itself also couples pneumatically to the extra-corporeal controller. The pump inlet of an extra-corporeal pump is connectable via a cannula to a patient&#39;s supra-diaphragmatic artery. The pump outlet of the extra-corporeal pump is connectable via a cannula to a patient&#39;s infra-diaphragmatic artery.  
           [0017]    In the method of the present invention, a doctor inserts into the patient the occluding device via a peripheral artery into the descending aorta, and positions the occluding device near the level of the patient&#39;s diaphragm. The occluding device catheter, coupled to the extra-corporeal controller, inflates and deflates the occluding device. The electrocardiogram ECG and proximal aortic blood pressure, measured in the upper arterial compartment via a lumen in the occluding device catheter, serve as inputs to cycle the occluding device synchronously with the heartbeat. The step of inflating occurs just prior to the start of cardiac systole co-pulsation and ventricular ejection. The extra-corporeal pump continuously or cyclically pumps blood from a supra-diaphragmatic-artery to a infra-diaphragmatic artery. The pumping flow rate varies in response to the end-systolic pressure measured in the upper arterial compartment of the patient&#39;s body. The step of deflating the aortic balloon occurs at the start of cardiac diastole and aortic valve closure. Deflating the balloon stabilizes the perfusion pressure between the upper and lower arterial compartments.  
           [0018]    In another feature of the present invention, the method of the present invention pumps blood from the patient&#39;s upper to the patient&#39;s lower arterial compartments.  
           [0019]    The present invention is designed to temporarily assist the failing human heart for a period of several hours to several days. The objectives of the heart-assist system of the present invention are to augment cardiac output and enhance systemic perfusion, reduce the workload and oxygen requirements of the acutely failing heart and allow for its recovery, allow for optimization of concomitant drug therapy, require minimal surgical intervention for insertion and removal, and reduce additional trauma to the failing heart by eliminating a need for direct cannulation of the left atrium or left ventricle. An additional feature of this technology is enhancement of diastolic perfusion by elevation of pressure throughout the diastolic interval and, unlike a commercially available balloon pump, enhancement of perfusion to all organs.  
           [0020]    The present invention allows for treatment of the failing heart in a minimally invasive manner with augmentation of left ventricular stoke volume cardiac output and simultaneous reduction in left ventricular workload and oxygen requirements of the heart.  
           [0021]    An important feature of the invention is that it rapidly inflates a small-volume balloon, partially occluding the aorta just prior to the start of cardiac systole and ventricular ejection. In another feature of the invention, it regulates aorta-aorta bypass blood pump flow to obtain a specific end-systolic aortic pressure measured in the upper arterial compartment. In another feature of the invention, decreasing end-systolic aortic pressure results in an increased ventricular stroke volume based on the ventricular pressure-volume-contractility relationship. Decreased systolic pressure also reduces the workload on the failing heart. Increased bypass pump blood flow elevates perfusion pressure in the lower arterial compartment. In another feature of the invention, during ventricular diastole, the system rapidly deflates an aortic balloon at end-systole. Deflating the aortic balloon stabilizes the perfusion pressure between the upper and lower arterial compartments. 
       
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       [0022]    [0022]FIG. 1 depicts an overview of the temporary heart-assist system, illustrating the intra-aortic balloon, aortic-aortic external bypass pump, and external controller, as installed on a patient.  
         [0023]    [0023]FIG. 2 is a detailed view of the intra-aortic balloon and associated catheter, illustrating some of their features.  
         [0024]    [0024]FIG. 3A is a schematic of the temporary heart-assist system, illustrating the intra-aortic balloon, aortic-aortic external bypass pump, and external controller, as installed on a patient.  
         [0025]    [0025]FIG. 3B is a schematic of a human heart, depicting part of an inlet catheter with the tip of the catheter positioned through the aortic valve into the left ventricle.  
         [0026]    [0026]FIG. 4 is a graph of the left ventricular-pressure-volume-contractility relationships for the normal heart, failing heart, and failing heart supported with the temporary heart-assist system according to the present invention.  
         [0027]    [0027]FIG. 5A is a graph showing the electrocardiogram and aortic blood pressures of the failing heart.  
         [0028]    [0028]FIG. 5B and FIG. 5C are graphs showing the electrocardiogram, aortic blood pressures, aortic balloon inflation/deflation timing, and bypass pump flow rate or motor speed with the temporary heart-assist system operating.  
         [0029]    [0029]FIG. 6A is a schematic of the external control unit illustrating manual controls, transducer inputs, monitor display, aortic balloon pneumatics, and bypass pump electronics.  
         [0030]    [0030]FIG. 6B is a schematic of the assist timing control panel, illustrating the method for setting the inflation and deflation timing of the aortic balloon.  
         [0031]    [0031]FIG. 6C is a schematic of the pressure assist control panel, illustrating the method for setting the degree of systolic pressure unloading of the heart.  
         [0032]    [0032]FIG. 6D is a detailed graph showing the control-logic loop for the heart assist system. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0033]    In the drawings, like numerals designate like parts throughout the drawings. In FIG. 1, a temporary heart-assist system  7  is illustrated in use with a human heart. The heart-assist system  7  includes an occluding device, or balloon,  8  in the patient&#39;s aorta, connected to a controller  9 , Which in turn connects to an extracorporeal aortic bypass blood pump  10 .The occluding device  8  can be any device that can be remotely opened and closed, either partially or fully, but in the preferred embodiment is a balloon. U.S. Pat. Nos. 5,894,273 and 6,137,416 disclose a limited-use controller that does not control an intra-aortic valve, such as the balloon  8 . Such a controller could be used to control the aortic bypass blood pump  10 . The deflated balloon  8  is mounted on the end of a flexible catheter  11 . The balloon  8  and catheter  11  are inserted into the aorta via a peripheral artery, preferably at a point  12  on the femoral artery. The catheter  11 may be inserted percutaneously over a guide wire or surgically by direct exposure of the vessel. The balloon  8  is positioned in the descending thoracic aorta at approximately the level of the diaphragm. More specifically, the balloon  8  is placed above the diaphragm, but below the subclavian artery.  
         [0034]    Referring now to FIG. 2, the aortic blood pressure AoP is recorded with two pressure transducers, or sensors  13  on the balloon  8 . The pressure transducers  13  are conventional transducers, such as model number BP01, manufactured by the InvenSys Company located in Milpitas, Calif. The controller  9  allows sustained flow to pump and reads upper and lower pressure for pump adjustments from the balloon sensors  13 . The balloon sensors  13  monitor pressure, and when pressure goes up then pump flow increases, and vice versa. The principle of the balloon  8  is to equalize pressure during systole, and to auto-regulate the flow rate of the pump  10 , based on the pressure sensed by the pressure sensors  13  on either side of the balloon  8 . The balloon  8  inflates as the aortic valve opens and deflates upon closure. If timed properly, there should be no period in which the aortic valve is closed and the balloon  8  inflated. In an alternate embodiment, only one sensor  13  is used.  
         [0035]    The catheter  11  has duel lumens. A larger lumen  14  is used to shuttle gas to and from the balloon  8  via openings or ports  15  located on a catheter wall. A smaller lumen  16  runs continuously through the body of the catheter  11 . The smaller lumen  16  is used for inserting the catheter  11  over an aortic guide wire and as a pressure transmission tube for the continuous measurement of central aortic pressure AoP proximal to the balloon  8  during operation of the heart-assist system  10 . The balloon  8  and catheter  11  are made of biocompatible polymeric materials. The balloon  8  and catheter  11  are flexible and nontraumatic to the aorta, but have a wall thickness and strength sufficient to withstand cyclic rapid balloon inflation and deflation.  
         [0036]    The pressure transducers  13  connect to the pressure transmission tube lumen  16 . The lumen  16  couples to a cable  18  that connects to the controller  9 . The balloon  8  is inflated and deflated by gas pressure, preferably using helium gas, supplied through a pneumatic tube  20  attached to the large lumen  14 . The tube  20  connects to the controller  9 . The balloon  8  deflates when depressurized with gas, and inflates when pressurized with gas, thereby partially or fully occluding the aorta. To avoid stagnation of the blood and vessel trauma, the balloon  8  does not need to completely occlude the descending aorta; it may leave some space on either side.  
         [0037]    Referring now to FIG. 3A, the left ventricle  22  of the heart is shown in systole with ejection of blood (long arrow) through the opened aortic outflow valve  24  into the ascending aorta  26 . An inlet cannula  38  for the pump  10  is inserted into the aorta at a point  40  proximal to the balloon  8 , using conventional surgical techniques. The point  40  may be in the ascending aorta  26 , for patients who have an open chest, or may be in a branch vessel, preferably the subclavian artery, for patients whose chest is not open, or at any point between.  
         [0038]    Referring now to FIG. 3B, in an alternate embodiment, the length of the inlet cannula  38  extends with its tip positioned through the aortic valve  24  into the left ventricle  22 . Holes  39  along the length of the inlet cannula  38  in the aorta, combined with a hole  39  in the tip of the cannula  38 , provide direct unloading of the left ventricle  22 , plus afterload reduction in the aorta.  
         [0039]    The lumen of the inlet cannula  38  is of sufficient size and capacity to allow flow rates (see arrow) up to 7 liters per minute, with minimal pressure drop and blood destruction hemolysis. U.S. Pat. No. 6,007,478 discloses a cannula having constant wall thickness with increasing distal flexibility. The full disclosure of this patent is incorporated herein by this reference. The inlet cannula  38  is brought out of the patient and connected to the pump  10 . The pump  10  is a commercially available non-pulsatile blood pump. Artificial heart pumps can be classified into the diaphragm type, the tube type, the roller pressure type, and the radial flow type that operates by rotational motion. Typical of the radial flow type is the centrifugal type. The following U.S. Patents disclose centrifugal heart pumps:  
                                                       5,894,273   Centrifugal blood pump driver apparatus           6,015,434   Artificial heart pump           6,137,416   Method of controlling centrifugal pump           6,227,817   Magnetically-suspended centrifugal blood pump                      
 
         [0040]    The full disclosures of these patents are all incorporated herein by this reference. The pump  10  may be any radial pump, but in the preferred embodiment the pump  10  is a centrifugal pump. A drive motor  42  powers the pump  10  via a magnetic coupling  44  located between the drive motor  42  and the pump  10 . The pump  10  has the capacity to pump up to 7 liters per minute of blood without increased hemolysis or thrombosis clot formation. Pump flow rate is continuously measured using a conventional flow transducer  45  connected to the controller  9 . The transducer  45  may be of the ultrasonic or electromagnetic type, but in the preferred embodiment is an ultrasonic model, made by Transonic Systems, Inc., located in Ithaca, N.Y. Blood returns to the patient via an outlet cannula  46  inserted in an infra-diaphragmatic artery at a point  48  far from the balloon  8 , using conventional surgical techniques. Preferably, the point  48  is in the femoral artery. The lumen of the outlet cannula  46  is of sufficient size and capacity to allow flow rates up to 7 liters per minute, with minimal pressure drop and hemolysis.  
         [0041]    An electrocardiogram (“ECG”) is recorded via electrodes  50  placed on the skin of the patient. The electrodes couple to cables  52  that connect to the controller  9 .  
         [0042]    The pump drive motor  42  couples to the controller  9  via a cable  62 . The purpose of the pump  10  is to pump blood from the upper arterial compartment  14  to the lower arterial compartment. During ventricular systole, and using. the ECG and aortic pressure-triggered controller  9 , the small-volume balloon  8  is rapidly inflated, partially occluding the aorta. In the preferred embodiment, the flow rate of the pump  10  is regulated to obtain a specific end-systolic AoP in the upper arterial compartment (aorta  26 ). However, in an alternate embodiment, the pump runs continuously at a set speed. A deceased end-systolic aortic pressure afterload results in an increase in cardiac output blood flow. Decreased afterload also reduces the workload and oxygen consumption of the failing heart. Increased systemic blood flow also elevates perfusion pressure in the lower arterial compartment. During ventricular diastole, the balloon  8  rapidly deflates, thereby increasing the perfusion pressure throughout the arterial compartment  26 . The pump flow rate can also be slowed during diastole by coasting or braking the motor  42 , thereby reducing the potential for blood trauma hemolysis. Decreasing pump flow may be obtained by coasting or braking the speed of the centrifugal pump motor. In an alternate embodiment, the pump  10  runs continuously at a set speed.  
         [0043]    Referring now to FIG. 4, the y-axis shows ventricular pressure 0-120 mmHg, and the x-axis shows ventricular volume 0-210 ml. An example of the pressure-volume relationship is shown for the normal N heart. Starting at the ventricular end-diastolic volume EDV for the normal heart N, the loop moves in a counter-clockwise direction. First the ventricle contracts and generates pressure sufficient to open the aortic valve AVO. The ventricle ejects blood into the aorta and the ventricular volume decreases. The ventricular stoke volume for each cardiac cycle is calculated by the formula: stoke volume ml/beat=EDV−ESV. At end-systole the aortic valve closes and pressure decreases as the walls of the ventricle relax during diastole. Following opening of the mitral valve MVO the left ventricle fills from the left atrium, containing oxygenated blood from the lungs, and ventricular volume increases. Contractility strength of contraction of the normal ventricle may be defined by the slope of the end-systolic pressure ESP-volume ESV relationship shown as solid line CN. Thus, for a given EDV, cardiac stroke volume decreases with increasing ESP and ESV. Conversely, stroke volume increases with decreasing ESP and ESV for a given EDV and contractility slope. With acute heart failure, the pressure-volume loop F 1  is shifted downward and to the right. For this heart failure example, the contractility slope shown as dashed line CF is reduced and the EDV is increased. Despite the increase in EDV and decrease in ESP, the cardiac stroke volume is reduced due to decreased contractility slope. Because of the decreased contractility slope, the ventricle is more sensitive to changes in the ESP. Otherwise stated, with heart failure small changes in ESP lead to larger changes in ESV compared to the normal ventricle.  
         [0044]    [0044]FIG. 4 also illustrates the effects of the embodiments of the present invention on the failing heart. With actuation of the aortic balloon  8  and the aortic-aortic bypass pump  10 , the left ventricle is pressure and volume unloaded. During ventricular systole, the aortic balloon  8  is inflated, occluding the aorta, and the bypass blood pump  10  transfers blood from the upper arterial compartment to the lower arterial compartment. Pump flow rate is controlled increased or decreased to result in a set ESP level. Compared to the unassisted condition loop F 1 , the reduced ESP during mechanical assistance results in a reduced ESV loop F 2  despite an unchanged contractility slope dashed line CF. Thus, reducing ESP and ESV with the heart-assist system  7  will increase cardiac stroke volume systemic perfusion and may also decrease ventricular EDV. Pressure and volume unloading of the ventricle also decreases systolic ventricular wall tension a primary component of cardiac muscle oxygen consumption.  
         [0045]    The aortic balloon  8  and aortic bypass pump  10  (axial or centrifugal flow device) are synchronously operated using the ECG-triggered and pressure-feedback controller  9 . During ventricular systole the small-volume balloon  8  is rapidly inflated, partially occluding the aorta. The flow rate of the aortic bypass blood pump  10  is regulated to obtain a specific end-systolic aortic pressure in the upper arterial compartment. A decreased end-systolic aortic pressure provided by the blood pump results in ventricular unloading and augmentation of systemic perfusion (stroke volume and cardiac output). The pump  10  assumes the circulation to the lower half of the body and the weakened heart is responsible for the upper half of the body only. Decreased afterload also reduces the workload on the failing heart. The increased systemic blood flow elevates perfusion pressure in the lower half of the body. During ventricular diastole, the balloon is deflated and the pump-generated pressure and flow increases the perfusion pressure throughout the arterial tree. Compared to the prior art intra-aortic balloon pumps, the invention provides greater augmentation of systemic perfusion, improved direct ventricular unloading, and increased diastolic perfusion, and without direct cannulation of the left ventricle or atrium as required for cardiac bypass devices.  
         [0046]    Because of aortic occlusion, the pump  10  flows from high pressure to lower pressure and will actually assume about 60% of the work. It is important to note that the pump  10  makes diastole become active. The pump  10  achieves systolic unloading by augmenting flow and increased blood flow during diastolic which reduces load to the heart.  
         [0047]    [0047]FIG. 5A and 5 b  illustrate the functioning of the heart-assist system  7 . FIG. 5A shows the ECG and AoP for the heart failure condition with the assist system  7  off. The ECG is recorded from skin electrodes appropriately placed on the patient. The R-wave  75  of the ECG corresponds with the start of ventricular systole and is used as a control trigger. The AoP shows the pressure recorded in the proximal aorta solid line and distal aorta dashed line. With the assist system off and the aortic balloon deflated, the proximal and distal aortic pressures are essentially equal. The start of systole  78  corresponds with the EDP time. The end of systole  79  corresponds with the ESP time. The systolic period S is when left ventricular ejection into the aorta occurs. The diastolic period D is when the ventricle relaxes and coronary perfusion occurs.  
         [0048]    Referring now to FIG. 5B and FIG. 5C, ,with the heart assist system  7  on, the aortic balloon is activated in two stages: inflation during ventricular systole S and deflation during cardiac diastole D. As shown in FIG. 5B and FIG. 5C, the R-wave of the ECG is used to trigger balloon inflation. The start of balloon inflation  90  is controlled to obtain a preset EDP level measured in the proximal aorta using the pressure transmission lumen  16  of the aortic catheter  11 . During inflation the balloon  8  makes uniform and firm contact with the inside wall of the aorta. This has the effect of blocking the downstream flow of blood in the aorta during systole. Thus, a closed volume is created between the outflow valve of the ventricle and the expanded balloon  8 .  
         [0049]    At the time of systolic S balloon inflation  90 , the aortic bypass pump shunts blood from the upper arterial compartment proximal aorta to the lower arterial compartment distal aorta. The centrifugal blood pump flow rate and RPM are regulated by the external controller  9  to obtain a preset ESP level measured in the aorta proximal to the inflated balloon. Thereby, the proximal aortic pressure is decreased solid line  80  and the distal aortic pressure is increased dashed line  82  during systole S compared to the unassisted condition shown in FIG. 5A. At the end of systole start of diastole, the aortic balloon is rapidly deflated  92 . Thus the aorta is opened between the upper and lower arterial compartments, and the two pressures equilibrate. The equilibration results in increased proximal solid line  84  and distal dashed line  86  aortic pressures during diastole D compared to the unassisted condition illustrated in FIG. 5A. Therefore, the heart-assist system described in the present invention is capable of increasing cardiac stroke volume and systemic perfusion, reducing ventricular workload and oxygen consumption, and increasing perfusion pressure to the coronary arteries supplying the heart. Also shown in FIG. 5B and FIG. 5C, the flow rate and RPM of the centrifugal aortic-aortic bypass pump may be increased  94  at the time to correspond  95  with aortic balloon inflation  90 . This provides for maximum pressure and volume unloading of the ventricle  80  and augmentation of distal perfusion pressure  82 . Additionally, the flow rate and RPM of the centrifugal blood pump may be decreased  97  at the time to correspond  98  with aortic balloon deflation  92 . The reduced flow rate may decrease the degree of pump-induced hemolysis.  
         [0050]    [0050]FIG. 6A illustrates the components of the heart-assist system control unit  9 . Manual controls  100  are used to set the timing of balloon inflation and deflation, and to set the degree of pressure assist provided by the centrifugal blood pump. The control unit contains preamplifiers  102  with EKG  52 , aortic pressure  18 , and pump flow  45  inputs. Control setting and transducer signals are passed through an A/D converter  104  with before being sent to the processor unit  106  and monitor display subsystem  108 . Based on transducer signals and control settings, the processor unit controls and monitors the pneumatic subsystem  110  that provides gas pressure and vacuum to inflate and deflate the aortic balloon, respectively, via a pneumatic drive line  20 . Processor unit  106  contains a microprocessor such as a Motorola 68HC11, random access memory (RAM) and program memory (PROM) which contains software to control the system. The processor unit also controls and monitors the motor control subsystem  112 , that sends power to the centrifugal blood pump drive motor via a electronic cable  64 .  
         [0051]    [0051]FIG. 6B illustrates the timing control panel  114 , on the external control unit, that is used for setting aortic balloon AoB inflation  116  and deflation  118  timing with respect to the R-wave of the electrocardiogram  75  as a percentage of the R-R time interval. With the assist pump and balloon turned off, the aortic balloon inflation time is established by manually moving the slide control  120  that controls a cursor line  122  simultaneously shown on the monitor display  108 . The slide control is moved such that the cursor line corresponds with end-diastole ED and the ED pressure  124  overlying the displayed aortic pressure waveform  126 . Additionally, balloon deflation time is established by manually moving the slide control  128  that controls a second cursor line  130  on the display monitor. The slide control is moved such that the cursor line corresponds with end-systole ES and the ES pressure  132  for the aortic pressure waveform. In the event that heart rate changes by +10 beats per minute, the assist pump and balloon should be turned off and the inflation and deflation timing reestablished.  
         [0052]    [0052]FIG. 6C illustrates the pressure assist Pa control panel  140 , on the external control unit, that is used for setting the degree of ventricular unloading provided by the aortic bypass pump. The degree of ventricular unloading is determined by the measured difference between the aortic end diastolic pressure EDP  142  and the end systolic pressure ESP  144 . A control knob  146  is manually set to establish the degree of pressure unloading which ranges from a negative 5 mmHg to a positive 5 mmHg. A control knob setting of 0 corresponds with the ESP=EDP. This setting provides a moderate level of ventricular unloading and heart assist. A setting of −5 corresponds with the ESP being 5 mmHg less than the corresponding EDP. This setting provides the maximum level of ventricular unloading and heart assist. A setting of +5 corresponds with the ESP being 5 mmHg more than the EDP. This setting provides the minimum level of ventricular unloading and is used for weaning from the heart assist system. The illustrated control method allows for beat-to-beat control of pump flow rate regardless of changes in the systemic vascular resistance and blood pressure. A manual push button  148  must be depressed simultaneously with changing the control knob setting. This method is used to prevent inadvertent changes in the pressure assist setting.  
         [0053]    [0053]FIG. 6D is a detailed flow diagram of the heart-assist system control logic  150 . Beat to beat control of the aortic occlusion balloon and aortic bypass pump is started with electrocardiogram R-wave detection  152 . With R-wave detection the timing clock and monitor displays are reset and the preceding R-R interval time is measured  154 . Based on the percentage ED and ES control setting  156  shown in FIG. 7, the ED and ES times in seconds is calculated  158  for the measured R-R interval  154 . Aortic balloon inflation IT and deflation DT times  160  are calculated by subtracting a known electromechanical delay time for the pneumatic subsystem from the previously calculated ED and ES times  158 , respectively. At the calculated balloon inflation time IT following R-wave detection, a trigger signal  162  is sent to the pneumatic subsystem  110  to provide drive gas to the aortic balloon. At the calculated ED time, the ED pressure EDP is measured  164  from the aortic pressure input signal. Based on the pressure assist control setting shown in FIG. 8, the calculated ES pressure ESPc  168  is determined using the formula: ESPc=measured EDP  164  minus the pressure assist Pa setting  146 . At the calculated balloon deflation time DT following R-wave detection, a trigger signal  170  is sent to the pneumatic subsystem  110  to exhaust drive gas from the aortic balloon. At the calculated ES time, the ES pressure ESP is measured  172  from the aortic pressure input signal.  
         [0054]    The calculated pressure difference Pdif  174  is determined using the formula: Pdif=measured ESP  172  minus the calculated ESPc  168 . The bypass pump speed RPM change is determined  176  based on the calculated Pdif  174 . Positive Pdif values result in increasing pump speeds. Conversely, negative Pdif values result in decreasing pump speeds. A speed control change signal  178  is sent to the motor control subsystem  112  which regulates centrifugal pump flow. Following the above steps, the control logic unit waits for the next R-wave detection  180 .  
         [0055]    Thus, the invention provides a method and apparatus for assisting the failing heart until such time that ventricular recovery and weaning from the assist system occurs. There are several advantages of this invention over prior intra-aortic balloon pump and ventricular assist devices. The invention is particularly useful in increasing cardiac output and decreasing ventricular loading without direct cannulation of the left atrium or left ventricle. The method includes controlled intermittent occlusion of the aorta synchronously with the cardiac cycle, accompanied by the pumping of blood from the proximal to the distal aorta at a rate sufficient to pressure and volume unload the failing left ventricle. Systolic ventricular unloading increases cardiac output and decreases myocardial oxygen demands. Augmented cardiac output levels also increase perfusion of the coronary arteries supplying oxygenated blood to the heart.  
         [0056]    Although the preferred embodiment of the present invention has been described above, it will be understood by those skilled in the art that numerous modifications from the present invention may be made without departing from the scope and meaning of the claims that follow.