System and Method For Monitoring Cardiac Blood Flow Balance Between The Right and Left Heart Chambers

Abstract

A system for measuring of cardiac blood flow balance parameter between the right chamber of the heart and the left chamber of the heart includes a sensor device for measuring one of blood pressure and blood flow rate and blood constituent concentration of a patient so as to generate an arterial pulse signal. A processing unit is responsive to the arterial pulse signal for generating a full arterial pulse signal, an arterio-venous pulse signal, and a balance parameter. A computational device is responsive to the balance parameter for further generating a set of physiological parameters. A display station device is responsive to the set of physiological parameters from the computational device for displaying meaningful information.

1 . A system for measuring of cardiac blood flow balance parameter between the right chamber of the heart and the left chamber of the heart, comprising:
 sensing means for measuring one of blood pressure and blood flow rate and blood constituent concentration of a patient so as to generate an arterial pulse signal;   processing means responsive to said arterial pulse signal for generating a full arterial pulse signal, defined as the measured arterial pulse signal without the effect of atrial diastolic blood flow demand;   said processing means for subtracting said arterial pulse signal from said full arterial pulse signal so as to generate an arterio-venous pulse signal;   said processing means further calculating a transfer function relationship of said arterio-venous pulse signal to said full arterial pulse signal to generate a balance parameter representation;   computational means being responsive to said balance parameter representation for further generating a set of physiological parameters; and   optional display monitoring means responsive to said set of physiological parameters from said processing means for displaying meaningful information.   
     
     
         2 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said transfer function relationship is the ratio of area under the curve of said arterio-venous (AV) pulse signal, measured by integration over the cardiac cycle, to said area under the curve of said full arterial pulse (FAP) signal, measured by integration over the same cardiac cycle. 
     
     
         3 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said transfer function relationship is a linear state-space model for said balance parameter. 
     
     
         4 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said transfer function relationship is a linear auto-regressive moving average model of said balance parameter. 
     
     
         5 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said set of physiological parameters are used to indicate a clinical assessment of a patient's health condition. 
     
     
         6 . A system for measuring of cardiac blood flow balance parameter claimed in  claim 1 , wherein said set of physiological parameters are used in the evaluation of therapy process status and/or in assessing and making decisions in the application of therapy protocol and steps. 
     
     
         7 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said set of physiological parameters are used to calculate oxygen consumption and oxygen delivery for the detection, diagnosis, and prediction of patients' disease state. 
     
     
         8 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said set of physiological parameters is used to control a medication delivery system for achieving target set points. 
     
     
         9 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said set of physiological parameters are used to identify, using system identification models, transfer function relationship for blood arterial supply and demand for a plurality of organs in the body of the patient to assess each organ's health state, or to comparatively assess their balance parameters. 
     
     
         10 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said set of physiological parameters is used to provide visual and audio monitoring of the patient's health condition, and alerting of abnormal events in patient's health condition. 
     
     
         11 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein further comprising wired or wireless telecommunication means for transmitting said set of physiological parameters from said processing means to said display monitoring means. 
     
     
         12 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said sensing means is attached to the patient using one of invasive, minimally invasive, and non-invasive techniques. 
     
     
         13 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said blood flow measurement is obtained by one of acoustic sensors, optical sensors, motion sensors, differential pressure sensors, thermodilution or agent dilution sensors, and coriolis sensors. 
     
     
         14 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said blood pressure measurement is obtained using one of invasive, minimally invasive, and non-invasive techniques. 
     
     
         15 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 14 , wherein said invasive technique includes placement of catheter or pressure sensing means in one of a vascular branch, a cardiac chamber, and body organ. 
     
     
         16 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 14 , wherein said minimally invasive technique includes using a cannula to access one of the artery and vein channels and using a pressure sensor to measure the vascular artery or vein pressure. 
     
     
         17 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 14 , wherein said non-invasive technique includes one of tonometric, optical, RF, acoustic, vibrational, and blood magneto-acoustic pulse sensing methods. 
     
     
         18 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said sensing means for measuring one of blood pressure and blood flow rate and blood constituent concentration is obtained by measurements from an artery, including one of aortic, carotid, pulmonary, femoral, radial, renal and hepatic arteries. 
     
     
         19 . A system for measuring of cardiac blood flow balance parameter as claimed in  claim 1 , wherein said sensing means for measuring one of blood pressure and blood flow rate and blood constituent concentration is obtained by measurements from a vein, including one of central venous, superior vena cava, inferior vena cava, jugular, pulmonary, femoral, radial, renal, and hepatic veins generate a venous pulse signal. 
     
     
         20 . A method for measuring of cardiac blood flow balance parameter between the right chamber of the heart and the left chamber of the heart, comprising the steps of:
 measuring with a sensor one of blood pressure and blood flow rate and blood constituent concentration of a patient so as to generate an arterial pulse signal;   calculating a full arterial pulse signal from the measured arterial pulse signal, defined as the measured arterial pulse signal without the effect of atrial diastolic blood flow demand;   calculating an arterio-venous pulse signal by subtracting said arterial pulse signal from said full arterial pulse signal;   generating a balance parameter by calculating a transfer function relationship of said arterio-venous pulse signal to said full arterial pulse signal; and   generating a set of physiological parameters in response to the balance parameter which are used to indicate a clinical assessment of a patient's health condition.   
     
     
         21 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein said transfer function relationship is the ratio of area under the curve of said arterio-venous pulse (AV) signal, measured by integration over the cardiac cycle, to area under the curve of said full arterial pulse (FAP), measured by integration over the cardiac cycle. 
     
     
         22 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein said transfer function relationship is a linear state-space model for said balance parameter. 
     
     
         23 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein said transfer function relationship is a linear auto-regressive moving average model of said balance parameter. 
     
     
         24 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the step of measuring includes the step of attaching the sensor to the patient using one of invasive, minimally invasive, and non-invasive techniques. 
     
     
         25 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the step of measuring the blood flow is obtained by one of acoustic sensors, motion sensors, differential pressure sensors, thermodilution or agent dilution sensors, and coriolis sensors. 
     
     
         26 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the step of measuring the blood pressure is obtained using one of invasive, minimally invasive, and non-invasive techniques. 
     
     
         27 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 26 , wherein said invasive technique includes the step of placing of catheter or pressure sensing means in one of a vascular branch, a cardiac chamber, and body organ. 
     
     
         28 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 26 , wherein said minimally invasive technique includes the step of using a cannula to access one of the artery and vein channels and using a pressure sensor to measure the vascular artery or vein pressure. 
     
     
         29 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 26 , wherein said non-invasive technique includes one of tonometric, optical, RF, acoustic, vibrational, and blood magneto-acoustic pulse sensing methods. 
     
     
         30 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the step of measuring one of blood pressure, blood flow rate, and blood constituent concentration is obtained by measurements from an artery, including one of aortic, carotid, pulmonary, femoral, radial, renal, and hepatic arteries. 
     
     
         31 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the step of measuring one of blood pressure, and blood flow rate, and blood constituent concentration is obtained by measurements from a vein, including one of central venous, superior vena cava, inferior vena cava, jugular, pulmonary, femoral, radial, renal, and hepatic veins generate a venous pulse signal. 
     
     
         32 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the derived cardiac balance parameter is used to optimize or control a cardiac pacemaker in one of location of leads placement, pacing power level, pacing pulse shape, pacing period, or pacing duty cycle. 
     
     
         33 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the derived cardiac balance parameter is used to detect and optionally alert against cardiac fibrillation or arrhythmia condition. 
     
     
         34 . The method of  claim 33 , where in the derived cardiac balance parameter is used to provide a cardiac defibrillator or cardioverter the detection of a cardiac fibrillation or arrhythmia condition. 
     
     
         35 . A method for measuring of cardiac blood flow balance parameter as claimed in  claim 20 , wherein the derived cardiac balance parameter is used to detect and alert against one of patient pain, surgical nociception, or cardiac stress. 
     
     
         36 . A method for clinically assessing of a patient's health condition, comprising the steps:
 generating a balance signal based upon an arterial pulse signal, a full arterial pulse signal, defined as the said arterial pulse signal without the effect of atrial diastolic blood flow demand, and an arterio-venous signal, defined as the subtraction of the said arterial pulse signal from the said full arterial pulse signal; and   assessing of the patient health condition based upon an analysis of the morphology of said balance signal.   
     
     
         37 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , further comprising the steps of providing a processor unit and configuring the processor unit to produce a transfer function which computes either the estimated full arterial pulse signal based upon the measured arterial pulse signal. 
     
     
         38 . A method for clinically assessing of a patient's health condition as claimed in  claim 37 , wherein said processor unit is comprised of microprocessor. 
     
     
         39 . A method for clinically assessing of a patient's health condition as claimed in  claim 38 , wherein said processor unit employs a system identification technique to define said transfer function. 
     
     
         40 . A method for clinically assessing of a patient's health condition as claimed in  claim 39 , wherein said system identification technique uses a linear state-space model identification. 
     
     
         41 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , wherein said balance signal provides physiological information of the heart. 
     
     
         42 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , wherein said balance signal provides physiological information of the brain. 
     
     
         43 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , wherein said balance signal provides physiological information of the lungs. 
     
     
         44 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , wherein said balance signal provides physiological information of a congestive heart failure condition. 
     
     
         45 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , wherein said balance signal provides physiological information of the body. 
     
     
         46 . A method for clinically assessing of a patient's health condition as claimed in  claim 36 , wherein said balance signal provides physiological information of the body's organ. 
     
     
         47 . A system for clinically assessing of a patient's health condition, comprising:
 means for generating a balance signal based upon an arterial pulse signal, a full arterial pulse signal, defined as the said arterial pulse signal without the effect of atrial diastolic blood flow demand, and an arterio-venous signal, defined by the subtraction of the said arterial pulse signal from the said full arterial pulse signal; and   means for assessing the patient health condition based upon an analysis of the morphology of said balance signal.   
     
     
         48 . A system for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein a processor unit is provided and configured to produce a transfer function which computes the estimated full arterial pulse signal based upon the measured arterial pulse signal. 
     
     
         49 . A system for clinically assessing of a patient's health condition as claimed in  claim 48 , wherein said processor unit is comprised of microprocessor. 
     
     
         50 . A system for clinically assessing of a patient's health condition as claimed in  claim 49 , wherein said processor unit employs a system identification technique to define said transfer function. 
     
     
         51 . A system for clinically assessing of a patient's health condition as claimed in  claim 50 , wherein said system identification technique uses a linear state-space model identification. 
     
     
         52 . A system for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein said balance signal provides physiological information of the heart. 
     
     
         53 . A system for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein said balance signal provides physiological information of the brain. 
     
     
         54 . A system for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein said balance signal provides physiological information of the lungs. 
     
     
         55 . A method for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein said balance signal provides physiological information of a congestive heart failure condition. 
     
     
         56 . A system for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein said balance signal provides physiological information of the body. 
     
     
         57 . A system for clinically assessing of a patient's health condition as claimed in  claim 47 , wherein said balance signal provides physiological information of the body's organ. 
     
     
         58 . A method for determining variability of a balance parameter between the left and right heart chambers to assess a patient's cardiac health state, comprising the steps of:
 measuring of an arterial pulse waveform signal using one of blood pressure and blood flow rate and blood constituent concentration;   calculating of a full arterial pulse waveform signal, defined as the arterial pulse signal without the effect of atrial diastolic blood flow demand, and an arterio-venous pressure waveform signal by subtraction of the measured arterial pressure waveform signal from the said full arterial pulse waveform signal;   determining a balance parameter for each heart pulse over a long duration of pulses;   separating the respiratory cycle component from the regulation cycle component;   applying frequency analysis to each of the separated respiratory and regulatory waveform components to detect the primary regulation and respiratory rate and characteristic components;   determining performance parameters for the respiratory cycle to provide one of respiration duty cycle, respiration rate, and heart rate, to monitor and provide alert for respiratory disorders including respiratory apnea, and respiratory suppression; or   determining performance parameters for the regulatory cycle to provide one of heart rate and regulation duty cycle, regulatory absence, and regulation abnormalities.   optionally displaying any useful information of the balance parameter, balance parameter variability, respiratory cycle, and regulatory cycle.   optionally alarming against any risk conditions provided by information of any of the balance parameter, balance parameter variability, respiratory cycle, and regulatory cycle.   optionally communicating via wired or wireless communications any useful information and related alarms of any of the balance parameter, balance parameter variability, respiratory cycle, and regulatory cycle.   
     
     
         59 . A method for determining variability of balance parameter as claimed in  claim 58 , further including the step of applying at least one of variance analysis and a filter to the balance parameter so as to smooth out the same. 
     
     
         60 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the balance parameter is a Left-Right Balance (LRB) parameter, wherein the said measured arterial pulse is one of aortic pulse or its arterial branches. 
     
     
         61 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the balance parameter is a Right-Left Balance (RLB) parameter, wherein the said measured arterial pulse is one of pulmonary artery pulse or its arterial branches. 
     
     
         62 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the step of separating includes applying adaptive filters. 
     
     
         63 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the step of separating includes applying demodulation to one of a respiratory signal carrier and a regulation signal carrier. 
     
     
         64 . A method for determining variability of a balance parameter as claimed in  claim 58 , further including the step of applying a peak-valley detection of the separated components of the respiratory cycle and the regulation cycle prior to the frequency analysis step. 
     
     
         65 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein when the variance of the balance parameter is higher than a threshold this is an indication of one of patient hydration status and cardiac abnormality, such as arrhythmia, ischemia, fibrillation, or myocardial infarction. 
     
     
         66 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein when the variance of the balance parameter is lower than a threshold this is an indication of one of patient hydration status and heart failure condition. 
     
     
         67 . The method claim of  58 , wherein systemic to pulmonary blood circulation balance parameter is determined as a transfer function relationship between the Left Right balance parameter (LRB) and the Right Left balance parameter (RLB). 
     
     
         68 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the respiratory performance parameters are used to control a ventilation device for respiratory ventilation of the patient. 
     
     
         69 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the balance parameter and autoregulation performance parameters are used to control a renal dialysis device for treating the patient. 
     
     
         70 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the balance parameter and autoregulation performance parameters are used to control a ventricular assist device or counter pulsation devices. 
     
     
         71 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the balance parameter and autoregulation performance parameters are used optimize and guide for cardiac pacing system lead placement. 
     
     
         72 . A method for determining variability of a balance parameter as claimed in  claim 58 , wherein the balance parameter and autoregulation performance parameters are used for one of monitoring, alerting, optimizing, and controlling blood flow delivery to one of a pregnant mother and her fetus baby.