# US 7,608,043 B1 · Optical and ultrasound probe for monitoring blood volume changes > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,608,043 B1 - Document ID: US7608043B1 - Status: Granted - Kind: B1 - Application number: 10/849,099 - Filed: 2004-05-19 - Granted: 2009-10-27 - Earliest claimed: 2002-10-18 - Assignees: Global Monitors, Inc. - Inventors: Lian-Pin Lee; Jen-Shih Lee - Web page: https://patentgrep.com/patent/US7608043B1 ## CPC - A61B 5/02042: {Determining blood loss or bleeding, e.g. during a surgical procedure} - A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)} - A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate} - A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea} - A61M 1/361: {before treatment} - A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621} - G01N 29/024: by measuring propagation velocity or propagation time of acoustic waves - G01N 29/222: {Constructional or flow details for analysing fluids (optoacoustic fluid cells G01N29/2425)} - A61B 8/06: Measuring blood flow - A61M 2205/3306: Optical measuring means - A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means - A61M 2230/207: hematocrit - G01N 2291/012: Phase angle - G01N 2291/02466: Biological material, e.g. blood - G01N 2291/02818: Density, viscosity - G01N 2291/102: one emitter, one receiver - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract An apparatus and method to assess the compressibility, density, and hematocrit of blood including an optical ultrasound probe clipped onto tubing in which blood is flowing. The probe includes a combination of ultrasound transducers, a light emitting diode, and photodiodes. An indicator medium is injected into the bloodstream of the subject over one or more time points. Ultrasound waves are emitted by a transducer and received by another transducer, and a novel signal-processing unit and a computer with a novel computation scheme process the ultrasound signals to assess the phase shift of ultrasound as it transmitted across the blood stream. ## Claims ### Claim 1 A system for monitoring changes in blood volume and microvascular pooling in animals, comprising: an extracorporeal blood treatment device comprising tubing having a first branch and second branch and a dialysis system, said first tubing branch conducting blood from an arterial segment of said blood system to said dialysis system, and said second tubing branch conducting blood from said dialysis system to a venous segment of said blood system; a diagnostic apparatus attached to said tubing of said extracorporeal blood treatment system wherein said diagnostic apparatus emits and receives an ultrasound wave and a light wave through blood flowing through said extracorporeal system; a signal processing system, wherein said signal processing system initiates and records ultrasound waves and light transmissions, determines phase shift between emitting and receiving ultrasound waves, monitors with high resolution sound velocity, density, compressibility, and optical density of blood, hematocrit, and plasma protein concentration, and assesses changes in said sound velocity, density, compressibility, optical density, hematocrit, and plasma protein concentration of modified blood at an equivalent temperature; an infusion system, said infusion system containing a known amount of an indicator fluid, said indicator fluid being infused into said blood system at an infusion connection located upstream of said dialysis system and diagnostic apparatus, wherein infusion of said indicator fluid into said blood system changes the density of said blood system as measured through said diagnostic apparatus and said signal processing system; a calibration system, said system including said signal processing system and a factory pre-calibrated probe; and a computing system for determining blood volume, changes in blood volume, changes in plasma protein concentration, and microvascular pooling from said hematocrit and density change. ### Claim 2 (depends on 1) The system of claim 1 wherein said signal processing system includes an ultrasound signal processing unit, an optical signal processing unit, an ultrasound and light generator, and two dual channel A/D converters. ### Claim 3 (depends on 2) The system of claim 2, wherein said calibration system employs data from said factory pre-calibrated probe on two fluids of known sound velocity to determine the relationship between the phase shift generated by said signal processing system and the sound velocity of blood for the assessment of compressibility and density of blood. ### Claim 4 (depends on 2) The system of claim 2, wherein said calibration system employs data from said factory pre-calibrated probe on a saline injection process to match the optical density measured by said optical processing unit with the density measurements made by said ultrasound signal processing unit to calibrate optical density in terms of hematocrit. ### Claim 5 (depends on 2) The system of claim 2 wherein said ultrasound wave is processed by said signal-processing system and said computer system using a novel computation scheme to determine the phase shift between emitting and receiving ultrasound. ### Claim 6 (depends on 1) The system of claim 1 wherein said human system is adapted to monitor blood changes in a human. ### Claim 7 (depends on 1) The system of claim 1 wherein said diagnostic apparatus is a clip-on probe having mounted thereon at least one ultrasound emitting transducer, at least one ultrasound receiving transducer, at least one light emitting diode, and at least two photodiodes. ### Claim 8 (depends on 7) The system of claim 7 wherein said at least one ultrasound emitting transducer, said at least one ultrasound receiving transducer, said at least one light emitting diode, and said at least two photodiodes are tightly clipped onto said tubing of said extracorporeal blood treatment device for transmission of ultrasound and light. ### Claim 9 (depends on 7) The system of claim 7 wherein said diagnostic apparatus further comprises a thermistor, wherein said thermistor takes a temperature measurement that is incorporated into a computation to convert measured sound velocity to density of blood. ### Claim 10 (depends on 1) The system of claim 1 wherein said indicator fluid is isotonic saline or dialysate. ### Claim 11 (depends on 1) The system of claim 1 wherein said dialysis unit is located upstream of said diagnostic apparatus. ### Claim 12 A system for monitoring changes in blood volume and microvascular pooling in animals, comprising: a diagnostic apparatus attached to an extracorporeal blood treatment device, said diagnostic apparatus emitting and receiving an ultrasound wave and a light wave through blood flowing through said blood treatment device, said blood treatment device being adapted to connect an artery and a vein of said animal; a signal processing system, wherein said signal processing system determines a phase shift between said emitting and receiving ultrasound wave, and determines absorbance and reflectance of said light wave; at least two control units within said signal processing system for detecting compressibility, density, hematocrit and plasma protein concentration with high resolution, for assessing changes in said compressibility, density, hematocrit, and plasma protein concentration at an equivalent temperature, for initiating and recording ultrasound and light waves, and for monitoring physical parameters of modified blood; and a computer memory unit for determining blood volume and microvascular pooling from said hematocrit and density change. ### Claim 13 (depends on 12) The system of claim 12 wherein said system is adapted to monitor blood changes in a human. ### Claim 14 (depends on 12) The system of claim 12 wherein said diagnostic apparatus is a clip-on probe having mounted thereon at least one ultrasound emitting transducer, at least one ultrasound receiving transducer, at least one light emitting diode, and at least two photodiodes. ### Claim 15 (depends on 12) The system of claim 12 further comprising a thermistor attached to said diagnostic apparatus. ### Claim 16 (depends on 12) The system of claim 12 further comprising an infusion device for diluting said blood via a dilution procedure wherein a known volume of said saline or dialysate is infused into said blood system for use in computing blood volume of the animal. ### Claim 17 A method for monitoring changes in blood volume and microvascular pooling in animals, comprising: conducting blood from a blood system to an extracorporeal blood treatment device and back into said blood system, said extracorporeal blood treatment device comprising tubing having a first branch and second branch and a dialysis system, said first tubing branch conducting blood from an arterial segment of said blood system to said dialysis system, and said second tubing branch conducting blood from said dialysis system to a venous segment of said blood system; emitting and receiving an ultrasound wave and a light wave through blood flowing through said extracorporeal blood treatment device via a diagnostic apparatus attached to said tubing of said extracorporeal blood treatment device; initiating and recording ultrasound waves and light transmissions; determining phase shift between emitting and receiving ultrasound waves; monitoring with high resolution sound velocity, density, compressibility, and optical density of blood, hematocrit, and plasma protein concentration; and assessing changes in said sound velocity, density, compressibility, optical density, hematocrit, and plasma protein concentration of modified blood at an equivalent temperature via a signal processing system; infusing an indicator fluid into said blood from said blood system via an infusion system connected to said extracorporeal blood treatment device, said infusion system containing a known amount of an indicator fluid, said indicator fluid being infused into said blood system at an infusion connection located upstream of said dialysis system and said diagnostic apparatus, wherein infusion of said indicator fluid into said blood system changes the density of said blood system as measured through said diagnostic apparatus and said signal processing system; calibrating phase shift as a function of density; and determining blood volume, changes in blood volume, changes in plasma protein concentration, and microvascular pooling from said hematocrit and density change via a computing system. ### Claim 18 (depends on 17) The method of claim 17 further comprising taking a temperature measurement of said blood via a thermistor and incorporating said temperature measurement into a computation to convert measured sound velocity to density of blood. ### Claim 19 (depends on 17) The method of claim 17 wherein said indicator fluid is isotonic saline or dialysate. ### Claim 20 (depends on 17) The method of claim 17 wherein said ultrasound wave is processed by said signal-processing system and said computer system using a computation scheme to determine the phase shift between emitting and receiving ultrasound.