Temporary heart assist system

Abstract

A balloon is positionable in the patient'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's infra-diaphragmatic artery. The pump inlet is connectable via a cannula to the patient's supra-diaphragmatic artery. A doctor inserts the balloon into the descending aorta, and positions the balloon near the level of the patient'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.

What is claimed is:  
     
         1 . A method for temporarily assisting a heart of a patient, the patient wearing ECG sensors with attached electrodes, the method comprising the steps of: 
 a. inserting an occluding device, having a pressure sensor, into the patient's descending aorta;    b. positioning the occluding device near the level of the patient's diaphragm;    c. coupling the occluding device to an extra-corporeal controller; and    d. opening and closing the balloon in response to signals from the ECG electrodes.    
     
     
         2 . The method of  claim 1 , wherein the step of closing occurs just prior to the start of cardiac systole and ventricular ejection.  
     
     
         3 . The method of  claim 2 , further comprising the step of using an extra-corporeal pump to continuously pump blood from a patient's supra-diaphragmatic artery to an infra-diaphragmatic artery.  
     
     
         4 . The method of  claim 3 , wherein in the step of continuously pumping blood, the pumping flow rate varies in response to the end-systolic pressure measured in the upper arterial compartment of the patient's body.  
     
     
         5 . The method of  claim 4 , wherein the extra-corporeal controller a) causes the occluding device to intermittently occlude the aorta, synchronously with the patient's cardiac cycle, and b) causes the extra-corporeal pump to pump blood from the patient's proximal to the distal aorta at a rate sufficient to pressure and volume unload the patient's failing left ventricle.  
     
     
         6 . The method of  claim 5 , wherein the extra-corporeal controller decreases the flow rate and RPM of the extra-corporeal pump when it opens the occluding device.  
     
     
         7 . The method of  claim 6 ,. wherein an inlet cannula of the extra-corporeal pump is inserted through an aortic valve into the left ventricle, the inlet cannula having holes along a length of it positioned in the aorta, and a hole in a tip, which is positioned in the left ventricle, for providing direct unloading of the left ventricle, and after-load reduction in the aorta.  
     
     
         8 . A method for temporarily assisting a heart of a patient, the patient wearing ECG sensors with attached electrodes, the method comprising the steps of: 
 a. inserting a balloon, having a balloon catheter and two pressure sensors, into the patient's descending aorta;    b. positioning the balloon near the level of the patient's diaphragm;    c. coupling the balloon catheter to an extra-corporeal controller;    d. inflating the balloon in response to signals from the ECG electrodes, and the two pressure sensors; and    e. deflating the balloon in response to signals from the ECG electrodes, and the two pressure sensors.    
     
     
         9 . The method of  claim 8 , wherein the step of inflating occurs just prior to the start of cardiac systole and ventricular ejection.  
     
     
         10 . The method of  claim 9 , further comprising the step of using an extra-corporeal pump to continuously pump blood from a patient's supra-diaphragmatic artery to an infra-diaphragmatic artery.  
     
     
         11 . The method of  claim 10 , wherein in the step of continuously pumping blood, the pumping flow rate varies in response to the end-systolic pressure measured in the upper arterial compartment of the patient's body.  
     
     
         12 . The method of  claim 11 , wherein the extra-corporeal controller a) causes the balloon to intermittently occlude the aorta, synchronously with the patient's cardiac cycle, and b) causes the extra-corporeal pump to pump blood from the patient's proximal to the distal aorta at a rate sufficient to pressure and volume unload the patient's failing left ventricle.  
     
     
         13 . The method of  claim 12 , wherein the extra-corporeal controller decreases the flow rate and RPM of the extra-corporeal pump when it deflates the balloon.  
     
     
         14 . A method for temporarily assisting a heart of a patient, the patient wearing ECG sensors with attached electrodes, and the patient also having an intra-aortic occluding device having two pressure sensors, the method comprising the steps of: 
 a. opening and closing the intra-aortic occluding device by an extra-corporeal controller in response to signals from the ECG electrodes and the two pressure sensors; and    b. continuously pumping blood by an extra-corporeal pump from a patient's supra-diaphragmatic artery to an infra-diaphragmatic artery    
     
     
         15 . The method of  claim 14 , wherein the step of closing occurs just prior to the start of the patient's cardiac systole and ventricular ejection.  
     
     
         16 . The method of  claim 15 , wherein the pumping flow rate varies in response to the end-systolic pressure measured in the upper arterial compartment of the patient's body.  
     
     
         17 . The method of  claim 16 , wherein the extra-corporeal controller a) causes the occluding device to intermittently occlude the aorta, synchronously with the patient's cardiac cycle, and b) causes the extra-corporeal pump to pump blood from the patient's proximal to the distal aorta at a rate sufficient to pressure and volume unload the patient's failing left ventricle.  
     
     
         18 . The method of  claim 11 , wherein the extra-corporeal controller decreases the flow rate and RPM of the extra-corporeal pump when it opens the occluding device.  
     
     
         19 . A method for temporarily assisting a heart of a patient, the patient wearing ECG sensors with attached electrodes, and the patient also having an intra-aortic balloon having two pressure sensors, the method comprising the steps of: 
 a. inflating the intra-aortic balloon by an extra-corporeal controller in response to signals from the ECG electrodes and the two pressure sensors;    b. deflating the intra-aortic balloon by an extra-corporeal controller in response to signals from the ECG electrodes and the two pressure sensors; and    c. continuously pumping blood by an extra-corporeal pump from a patient's supra-diaphragmatic artery to an infra-diaphragmatic artery.    
     
     
         20 . The method of  claim 19 , wherein the step of inflating occurs at the onset or during the patient's cardiac systole and ventricular ejection.  
     
     
         21 . The method of  claim 20 , wherein the pumping flow rate varies in response to the end-systolic pressure measured in the upper arterial compartment of the patient's body.  
     
     
         22 . The method of  claim 21 , wherein the extra-corporeal controller a) causes the balloon to intermittently occlude the aorta, synchronously with the patient's cardiac cycle, and b) causes the extra-corporeal pump to pump blood from the patient's proximal to the distal aorta at a rate sufficient to pressure and volume unload the patient's failing left ventricle.  
     
     
         23 . The method of  claim 22 , wherein the extra-corporeal controller decreases the flow rate and RPM of the extra-corporeal pump when it deflates the balloon.