Hemodynamic Detection of Circulatory Anomalies
First Claim
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1. A method for detecting the presence of a right-to-left pulmonary shunt in a patient, the improvement comprising the steps:
- providing an elongate air conduit having proximal end configured to be positioned within the mouth of the patient to receive exhaled breath, and having a distal end configured for air pressure secure attachment with a pressure transducer;
providing an indicator delivery system having an outlet located in a vein of the patient in blood flow communication with the right side of the heart of the patient and actuateable by an operator to inject a predetermined amount of metabolically compatible indicator into the vein for travel to the right side of the heart of the patient;
providing an indicator sensor located with respect to arterial vasculature and having an output corresponding with the instantaneous concentration of indicator at such vasculature; and
providing a monitor/controller having a display and supporting the pressure transducer in attachment with the air conduit distal end and having a pressure output signal, responsive to such pressure output signal reaching and at least maintaining a predetermined corresponding pressure threshold value to provide a visual representation thereof at the display and commence a test timing, responsive to the test timing to cue the operator to actuate the indicator delivery system, responsive to the sensor output to determine whether a shunt is present.
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Abstract
The preferred indicator is an injection of indocyanine green dye which is detected and quantified by causing it to fluoresce at a sensor location, for example, at the human ear. Quantification is carried out by using cardiac output procedures and where called for, the Valsalva Maneuver is monitored at a monitor/controller giving visual cues to the patient and operator as to the quality of the necessary exhalation pressure maintenance.
61 Citations
44 Claims
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1. A method for detecting the presence of a right-to-left pulmonary shunt in a patient, the improvement comprising the steps:
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providing an elongate air conduit having proximal end configured to be positioned within the mouth of the patient to receive exhaled breath, and having a distal end configured for air pressure secure attachment with a pressure transducer; providing an indicator delivery system having an outlet located in a vein of the patient in blood flow communication with the right side of the heart of the patient and actuateable by an operator to inject a predetermined amount of metabolically compatible indicator into the vein for travel to the right side of the heart of the patient; providing an indicator sensor located with respect to arterial vasculature and having an output corresponding with the instantaneous concentration of indicator at such vasculature; and providing a monitor/controller having a display and supporting the pressure transducer in attachment with the air conduit distal end and having a pressure output signal, responsive to such pressure output signal reaching and at least maintaining a predetermined corresponding pressure threshold value to provide a visual representation thereof at the display and commence a test timing, responsive to the test timing to cue the operator to actuate the indicator delivery system, responsive to the sensor output to determine whether a shunt is present. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 26)
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15. A system for detecting the presence of one or more right-to-left cardiac shunts in a patient, comprising;
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an indicator delivery assembly having an injection outlet located in a vein of the patient in blood flow communication with the right side of the heart of the patient and actuateable by an operator to inject a predetermined amount of indicator into the vein for travel to the right side of the heart of the patient; an indicator sensor located with respect to arterial vasculature and having a concentrator output corresponding with the instantaneous concentration of indicator at such vasculature; a heart rate monitor attachable in monitoring relationship with the patient, having a heart rate output correspond with the heart rate of the patient and a monitor/controller having a display, responsive to commence timing for test elapsed time and cue the operator to actuate the indicator delivery assembly, responsive to the concentrator output, the average heart rate output, the body surface area of the patient, and known normal value for the stroke index of the heart to calculate cardiac output, responsive to calculate the area Anormal under a normal indicator/dilution curve as associated with indicator and blood flowing through a normal pathway through and from the lungs of the patient, and responsive to calculate the area under any premature indicator/dilution curve associated with one or more right-to-left shunts which occur prior to the normal indicator/dilution curve. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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27. A method for quantifying the extent of a circulatory anomaly in a patient comprising the steps;
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an indicator delivery assembly having an injection outlet located in a vein of the patient in blood flow communication with the right side of the heart of the patient and actuateable by an operator to inject a predetermined indicator bolus into the vein for travel to the right side of the heart of the patient; an indicator sensor located with respect to arterial vasculature and having a concentrator output corresponding with the instantaneous concentration of indicator at such vasculature; a heart rate monitor attachable in monitoring relationship with the patient, having a heart rate output correspond with the heart rate of the patient and a monitor/controller having a display, responsive to commence timing for test elapsed time and cue the operator to actuate the indicator delivery assembly, responsive to the concentrator output, the average heart rate output, the body surface area of the patient, and known normal value for the stroke index of the heart to calculate cardiac output, responsive to calculate the area A normal under a normal indicator/dilution curve as associated with indicator and blood flowing through a normal pathway from the lungs of the patient, and responsive to calculate the area under any premature indicator/dilution curve associated with one or more right-to-left shunts which occur prior to the normal indicator/dilution curve. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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38. A sensor apparatus comprising
(a) an emitter-detector pair for monitoring the fluorescence of a fluorescing circulatory tracking reagent; -
b) said emitter providing a light source emitting a first wavelength for the transcutaneous excitation of an indicator within the bloodstream; and (c) said detector for measuring the intensity of the light emitted at a second wavelength from an indicator within the blood stream. - View Dependent Claims (39, 40, 41, 42)
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43. A kit supplying consumable materials necessary for quantifying a circulatory anomaly comprising a dose of circulatory indicator reagent as a shelf stable material;
- a diluent for preparing the dose of circulatory indicator reagent for injection;
a syringe and needle apparatus for mixing the dose of circulatory indicator reagent and the diluent and suitable for injecting the dose into an injection port; and
a dose of nonreactive blood compatible clearing reagent for completing the injection.
- a diluent for preparing the dose of circulatory indicator reagent for injection;
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44. A method of determining the efficacy of circulatory tracking systems comprising
a) providing a test animal with a functioning circulatory system and heart; -
b) emplacing an injection catheter into the circulatory system or a chamber of the heart in the test animal; c) providing a test circulatory tracking reagent; d) providing a detector compatible with the circulatory tracking reagent; and e) one or more detector emplacement locations on the body of the test animal, wherein a bolus of circulatory tracking reagent is injected into the circulatory system or chamber of the heart, and the detector is emplaced on the body of the test animal such that the efficacy of a combination of given detectors to detect the presence of given circulatory tracking agents at a particular location on the test animal body may be determined.
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Specification