Abstract: A method for detection, localization, and quantification anatomical, morphological or structural features of site sites by analyzing data acquired before injection of a contrast agent and after injection the contrast agent. New catheters for use with the method is also disclosed.

Abstract: The present invention relates to assessing and measuring vascular and endothelial function. A vasostimulant is provided to a patient to stimulate hemodynamic activity in a selected extremity and vascular function is assessed by monitoring a change in a blood flow, skin temperature and/or blood oxygen content at the selected extremity and assessing the patient's vascular function based upon the monitoring.

Abstract: Methods and devices are disclosed for detecting vulnerable atherosclerotic plaque, or plaque at risk of reducing blood flow in a vessel, by identifying a region of elevated temperature along a living vessel wall. The disclosure that human atherosclerotic plaque with measurable temperature heterogeneity has the morphological characteristics of plaque that is likely to ulcerate provides a new and sensitive technique for detecting and treating these dangerous plaques before myocardial infarction and its consequences occur. The disclosed methods are advantageous over conventional plaque detection techniques because they are capable of differentiating between those plaques that are at great risk of rupture, fissure, or ulceration, and consequent thrombosis and occlusion of the artery, and those that are not presently at risk. Infrared heat-sensing catheters useful for identifying potentially fatal arterial plaques in patients with disease of the coronary or other arteries are also described.

Abstract: Methods and apparatus are provided for determining individual responses to induced and actual mental stress and for identifying individuals susceptible to detrimental effects of mental stress on the cardiovascular system. The subjects may be at risk for chronic effects of mental stress by virtue of synergistic effects of mental stress and cardiovascular (CV) disease risk factors) or may be at risk, or vulnerable to, acute effects of mental stress by virtue of synergistic effects of mental stress and underlying hidden coronary atherosclerosis. The invention further provides methods and apparatus for assessing vascular reactivity in individuals under ambulatory conditions and relating mental stress responses to vascular reactivity.

Abstract: A set of intravascular ultrasound (IVUS) related systems, apparatuses and methods are disclosed. New catheter designs including contrast agent introduction subsystems and/or Doppler subsystems are disclosed. Methods for acquiring and analyzing Doppler data from intravascular ultrasound (IVUS) catheters are disclosed. RF-based detection of blood and/or contrast agents such as micro-bubbles are disclosed. Methods for frame-grating image data analysis permitting frame registration before, during and after a contrasting effect is imposed on a system being imaged are disclosed. Methods for difference imaging for contrast detection are disclosed. Methods for quantification and visualization of IVUS data are disclosed. And methods for IVUS imaging are disclosed.

Abstract: Methods and apparatus are provided for assessing the risk of an acute cardiovascular event that includes providing an endothelial or vascular function test to identify higher risk from lower risk individuals in a population of symptomatic individuals presenting with chest pain that have inconclusive results in ECG and cardiovascular marker tests, such as a tropinin test, and are administered for triage in hospital and additional tests such as ECG exercise and nuclear stress tests. The invention further provides methods and apparatus for assessing the vascular status and response of patients in clinical trials for cardiovascular therapies.

Abstract: The present invention is directed to methods and apparatus for modulation of the sympathetic-parasympathetic balance by application of heat, carotid and/or ocular message to reduce sympathetic tone or increase parasympathetic tone in a target muscle system to relieve a symptom of urinary hesitancy, shy bladder syndrome, DESD, urinary retention, or laryngeal spasm, as well as to monitor the efficacy of treatments for bladder conditions and to assist in the passage of medical devices through bodily sphincters as well as to treat congestive heart failure.

Abstract: Apparatus and methods for comprehensive assessment of vascular health is provided including functional status of the individual, risk factor assessment based on epidemiologic studies, and structural studies of the individual. Functional assessment in accordance with an embodiment of the invention includes generation of information on the status of three compartments: the microvasculature, the macrovasculature and the neurovasculature.

Abstract: The present invention provides methods and apparatus for assessing a patient's vascular health including endothelial function by monitoring changes in hemodynamic parameters responsive to the introduction of a vasostimulant. The invention provides a thermal energy measurement apparatus including a thermal energy sensor adapted to measure temperature of a body part while not substantially changing the temperature of the body part, and a display or recorder coupled to the thermal energy sensor, wherein the thermal energy sensor measures the temperature of the body part before and subsequent to the provision of a vasostimulant, and the display or recorder reports the temperature of the body part prior to the provision of the stimulant and the temperature of the body part after provision of the stimulant.

Abstract: Methods and apparatus are provided for identifying and minimizing neurovascular contributions to determinations of endothelial function, including by digital temperature monitoring such that an accurate status of vascular reactivity can be obtained. Methods are also provided for identifying individuals having increased sympathetic nervous system activity impacting peripheral vascular function as well as for determining a status of diabetic foot.

Abstract: Methods and apparatus are provided for determining individual vascular responses by employing iontophoresis to deliver vasoactive compounds to local area and determining resultant changes in blood flow by measuring changes in skin temperature as a correlate of local blood flow. The invention further provides methods and apparatus for assessing vascular reactivity in individuals under ambulatory conditions and relating stress responses to vascular reactivity.

Abstract: The present invention is directed to methods and apparatus for modulation of the sympathetic-parasympathetic balance by application of heat, carotid and/or ocular message to reduce sympathetic tone or increase parasympathetic tone in a target muscle system to relieve a symptom of urinary hesitancy, shy bladder syndrome, DESD, urinary retention, or laryngeal spasm, as well as to monitor the efficacy of treatments for bladder conditions and to assist in the passage of medical devices through bodily sphincters as well as to treat congestive heart failure.

Abstract: The present invention relates to assessing and measuring endothelial functions. A vasodilating stimulant is provided to a patient to stimulate hemodynamic activity in a selected region of the patient's body. In an embodiment, endothelial function may then be assessed by monitoring a change in a hemodynamic parameter at the selected region and assessing the patient's endothelial function based upon that monitoring. In a further embodiment, endothelial function may then be measured by monitoring a change in blood oxygen content at the selected region and assessing the patient's endothelial function based upon that monitoring. In yet a further embodiment, endothelial function may then be measured by monitoring a change in blood flow rate at the selected region and assessing the patient's endothelial function based upon said monitoring.

Abstract: The present invention discloses a device and methods for characterizing vulnerable plaque and cancer tissue by measuring changes in tissue elasticity compared to that of normal tissue. The system includes a catheter with an expandable element at a proximal end. The expandable element is equipped with pressure sensors to detect changes in tissue elasticity and can be additionally equipped with sensors that detect tissue temperature and pH. For arterial tissue or tissue lining a body cavity, the device can also be equipped with width gauges that measure the diameter of the artery lumen or the width of any section of the body cavity. The distal end of the catheter may be attached to a motorized pullback device connected to a computer. Data collected by the device sensors are sent to the computer for processing and analysis.

Abstract: The present invention relates to an intraluminal magnetic resonance imaging (MRI) probe which may be used for intraluminal MRI. The present invention is sized sufficiently small to be inserted into a patient intraluminally. The probe of the present invention comprises a substrate having a dielectric constant in the range of 1-1000, and first and second conducting layers on each side of the dielectric. The present invention is configured to result in a distributed capacitance.

Abstract: Methods and devices are disclosed for detecting vulnerable atherosclerotic plaque, or plaque at risk of reducing blood flow in a vessel, by a identifying a region of elevated temperature along a living vessel wall. The disclosure that human atherosclerotic plaque with measurable temperature heterogeneity has the morphological characteristics of plaque that is likely to ulcerate provides a new and sensitive technique for detecting and treating these dangerous plaques before myocardial infarction and its consequences occur. The disclosed methods are advantageous over conventional plaque detection techniques because they are capable of differentiating between those plaques that are at great risk of rupture, fissure, or ulceration, and consequent thrombosis and occlusion of the artery and those that are not presently at risk. Infrared heat-sensing catheters useful for identifying potentially fatal arterial plaques in patients with disease of the coronary or other arteries are also described.

Abstract: The present invention relates to a system and method for using an analysis of data generated during a scan of a patient to aid in assessment of coronary risk based upon coronary calcification. In an embodiment, a region of interest in a patient is scanned using computed tomography (CT). CT generated data resulting from the scanning are stored where the data comprise calcification data. The data are analyzed to determine a distribution of calcification in the patient and the patient's risk of cardiovascular disease based upon the analysis is assessed. It is emphasized that this abstract is provided to comply with the rules requiring an abstract which will allow a searcher or other reader to quickly ascertain the subject matter of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Abstract: Methods for the detection of inflammation associated with vulnerable atherosclerotic plaque to prevent heart attack and stroke are disclosed. The methods are also applicable to detection of infection, cancer, wounds or auto-immune disease in the body. Certain embodiments of the new methods provide a way of predicting the level of vulnerability of an atherosclerotic plaque to rupture or thrombus formation by assessing via fiber optic NIR spectrophotometry the status of two or more parameters associated with inflamed atherosclerotic plaque in a vessel of a living patient. From these measurements such conditions as low pH, hypoxia, low glucose, oxidative stress or compounds abundant in vulnerable plaque such as oxidized LDL cholesterol and oxidized metabolites of NO, significant active macrophage population, thin plaque cap, as well as senescence and/or apoptosis of smooth muscle or endothelial cells are determined with the assistance of a suitably programmed microprocessor.

Abstract: The present invention relates generally to a system and methods for local delivery of drugs directly to the coronary circulation which may be isolated from systemic circulation. More especially it relates to a dialysis system and methods of infusing beneficial drugs, therapeutic agents, and/or other beneficial substances, including high doses of these, such as HDL, therapeutic genes, and/or chelating agents to the coronary system. The multi-chambered dialysis machine in the present system is capable of removing unwanted/harmful substances from the blood, enriching and/or otherwise processing the blood, and re-circulating the processed blood back to the coronary circulation of patient. It is emphasized that this abstract is provided to comply with the rules requiring an abstract which will allow a searcher or other reader to quickly ascertain the subject matter of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Abstract: The present invention discloses a device and methods for characterizing vulnerable plaque and cancer tissue by measuring changes in tissue elasticity compared to that of normal tissue. The system includes a catheter with an expandable element at a proximal end. The expandable element is equipped with pressure sensors to detect changes in tissue elasticity and can be additionally equipped with sensors that detect tissue temperature and pH. For arterial tissue or tissue lining a body cavity, the device can also be equipped with width gauges that measure the diameter of the artery lumen or the width of any section of the body cavity. The distal end of the catheter may be attached to a motorized pullback device connected to a computer. Data collected by the device sensors are sent to the computer for processing and analysis.