Decision support systems and methods for assessing vascular health

Abstract

The present invention relates generally to systems and methods for assessing blood flow in blood vessels, for assessing vascular health, for conducting clinical trials, for screening therapeutic interventions for adverse effects, and for assessing the effects of risk factors, therapies and substances, including therapeutic substances, on blood vessels, especially cerebral blood vessels, all achieved by measuring various parameters of blood flow in one or more vessels and analyzing the results in a defined matter. The relevant parameters of blood flow include mean flow velocity, systolic acceleration, and pulsatility index. By measuring and analyzing these parameters, one can ascertain the vascular health of a particular vessel, multiple vessels and an individual. Such measurements can also determine whether a substance has an effect, either deleterious or advantageous, on vascular health. In one of many embodiments, the present invention further provides an expert system for achieving the above.

1 . A method of assessing vascular health in a human or an animal, the method of assessing vascular health comprising the steps of: 
 measuring information concerning flow velocity within a subject's blood vessels;    obtaining a mean flow velocity value for each measured vessel;    obtaining a systolic acceleration value for the vessel;    inputting the measured information into a processor containing an algorithm wherein the processor performs calculations of mean flow velocity, and systolic acceleration, and performs comparisons to analyze vascular health; and    outputting an assessment indicative of the subject's vascular health.    
     
     
         2 . The method according to  claim 1 , further comprising the step of obtaining a pulsatility index.  
     
     
         3 . The method according to  claim 1  wherein the vessel is an artery.  
     
     
         4 . The method according to  claim 3 , wherein the artery supplies the central nervous system.  
     
     
         5 . The method according to  claim 3 , wherein the artery is the common carotid, internal carotid, external carotid, middle cerebral, anterior cerebral, posterior cerebral, anterior communicating, posterior communicating, vertebral, basilar, ophthalmic, or branches thereof.  
     
     
         6 . The method according to  claim 1 , wherein the vessel is an intracranial vessel.  
     
     
         7 . The method according to  claim 1 , wherein ultrasound energy is used to collect the information concerning flow velocity.  
     
     
         8 . The method according to  claim 7 , wherein a Doppler probe is used to collect the information concerning flow velocity.  
     
     
         9 . A method of determining effects of a substance on a vessel comprising application of the method according to  claim 1  before and after administration of the substance.  
     
     
         10 . The method according to  claim 9  wherein the substance is a drug.  
     
     
         11 . The method according to  claim 10  wherein the substance is a vasoactive drug.  
     
     
         12 . The method according to  claim 10  wherein the substance is suspected of having vascular activity.  
     
     
         13 . The method according to  claim 1  wherein the human or the animal has a vascular disease or a condition that affects vascular function.  
     
     
         14 . The method according to  claim 1  wherein the human or the animal is suspected of having a vascular disease or a condition that affects vascular function.  
     
     
         15 . The method according to  claim 1 , wherein the human or the animal is analyzed at a time of normal and at a time of abnormal health.  
     
     
         16 . A method of analyzing the vascular structure of a human or an animal, the method of analyzing comprising the steps of: 
 accessing transcranial Doppler data with data collected from multiple subjects, wherein the data from each subject is collected from at least one intracranial blood vessel;    analyzing said data to establish multiple references indicative of the health status of individuals;    obtaining transcranial Doppler data from an individual;    inputting the individual's data into a processor;    comparing the individual's data to the references; and    outputting an analysis based on such comparison.    
     
     
         17 . The method according to  claim 16 , further comprising the steps of; 
 obtaining an analysis of the individual's data from a health professional; and    comparing the analysis outputted by the processor to the analysis generated by the health professional.    
     
     
         18 . The method according to  claim 17 , further comprising the step of modifying the references to incorporate the analysis of the health professional.  
     
     
         19 . The method according to  claim 17 , further comprising the step of using the comparison to educate health professionals.  
     
     
         20 . The method according to  claim 17 , further comprising the step of using the comparison for quality control associated with the analysis transmitted to an individual.  
     
     
         21 . The method according to  claim 16 , wherein the references include a reference based on measurements of systolic acceleration.  
     
     
         22 . The method according to  claim 21 , wherein the references include a reference based on measurements of the index of pulsatility.  
     
     
         23 . The method according to  claim 21 , wherein the references include a reference based on measurements of the mean blood-flow velocity.  
     
     
         24 . The method according to  claim 22 , wherein the references include a reference based on measurements of the mean blood flow velocity.  
     
     
         25 . A method of analyzing the vascular structure of a human or animal, the method of analyzing comprising the steps of: 
 inputting blood flow measurements of the subject sufficient to derive systolic acceleration into a processor;    applying algorithms to the subject's blood flow measurements including calculations based on the subject's systolic acceleration; and    outputting an analysis of the subject.    
     
     
         26 . The method of analyzing the vascular structure of a human or animal according to  claim 25 , wherein the intermediate calculations of the algorithms are outputted for analysis by health professionals.  
     
     
         27 . The method of analyzing the vascular structure of a human or animal according to  claim 26 , wherein the algorithms are modified based on the analysis of the health professional.  
     
     
         28 . The method of analyzing the vascular structure of a human or animal according to  claim 25 , wherein the algorithms include calculations based on the subject's index of pulsatility.  
     
     
         29 . The method of analyzing the vascular structure of a human or animal according to  claim 28 , wherein the algorithms include calculations based on the subject's mean blood flow velocity.  
     
     
         30 . The method of analyzing the vascular structure of a human or animal according to  claim 29 , wherein the measurements of the subject come from at least three blood vessels.  
     
     
         31 . The method of analyzing the vascular structure of a human or animal according to  claim 29 , wherein the measurements of the subject are intracranial.  
     
     
         32 . A method of assessing of the vascular health of a subject through analysis of multiple vascular measurements, the method of assessing comprising the steps of: 
 obtaining blood flow parameters from multiple vascular measurements;    inputting patient data and data regarding related pathologies;    accessing a system embodying the process of reasoning from blood flow parameters, patient data, and data regarding related pathologies to an assessment of vascular health; and    outputting an assessment of the subject's vascular health.    
     
     
         33 . The method according to  claim 32  wherein the vascular measurements comprise data collected via ultrasound energy.  
     
     
         34 . The method according to  claim 33  wherein the vascular measurements are collected using a Doppler probe.  
     
     
         35 . The method according to  claim 34  wherein the vascular measurements comprise transcranial Doppler data.  
     
     
         36 . The method according to  claim 32  wherein the blood flow parameters comprise mean flow velocity and systolic acceleration.  
     
     
         37 . The method according to  claim 36  wherein a data set comprising mean flow velocity and the systolic acceleration comprise a characterization of vascular health, and 
 the method further comprising the step of comparing the characterization of vascular health of the subject to a set of characterizations of vascular health of a reference population.  
 
     
     
         38 . The method according to  claim 37  wherein the system comprises a Bayesian belief network.  
     
     
         39 . The method according to  claim 36  wherein the blood flow parameters further comprise a pulsatility index.  
     
     
         40 . The method according to  claim 39  wherein a data set comprising mean flow velocity, systolic acceleration, and pulsatility index comprise a characterization of vascular heath, and 
 the method further comprising the step of comparing the characterization of vascular health of the subject to a set of characterizations of vascular health of a reference population.  
 
     
     
         41 . The method according to  claim 40  wherein the system comprises a Bayesian belief network.  
     
     
         42 . The method according to  claim 32  wherein the system comprises a transparent Bayesian belief network.  
     
     
         43 . The method according to  claim 32  wherein an artery is one subject of the multiple vascular measurements.  
     
     
         44 . The method according to  claim 43  wherein the artery supplies the central nervous system.  
     
     
         45 . The method according to  claim 43  wherein the artery is one selected from the group consisting of the common carotid, the internal carotid, the external carotid, the middle cerebral, the anterior cerebral, the posterior cerebral, the anterior communicating, the posterior communicating, the vertebral, the basilar, ophthalmic, and branches thereof.  
     
     
         46 . The method according to  claim 32  wherein an intracranial vessel is the subject of the vascular measurements.  
     
     
         47 . The method according to  claim 32  wherein the vascular measurements comprise data from at least three blood vessels.  
     
     
         48 . The method of  claim 47  wherein the blood vessels are intracranial vessels associated with the cerebrovasculature.  
     
     
         49 . The method of  claim 32  wherein the system accepts and incorporates input from a user regarding relationships and probabilities within the process of reasoning.  
     
     
         50 . The method of  claim 41  wherein the system accepts and incorporates input from a user regarding relationships and probabilities within the process of reasoning.