# US 10,441,707 B2 · System and method for extracorporeal temperature control > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,707 B2 - Document ID: US10441707B2 - Status: Granted - Kind: B2 - Application number: 15/329,204 - Filed: 2015-08-05 - Published: 2017-08-31 - Granted: 2019-10-15 - Earliest claimed: 2014-08-14 - Assignees: Medivance Incorporated - Applicants: Medivance Incorporated - Inventors: Marc E. Voorhees; Christopher Park; Salvatore Privitera - Web page: https://patentgrep.com/patent/US10441707B2 ## CPC - A61M 1/369: {Temperature treatment} - A61F 7/0085: {Devices for generating hot or cold treatment fluids} - A61F 7/12: Devices for heating or cooling internal body cavities - A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor - A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines - A61M 60/515: Regulation using real-time patient data - A61F 2007/0056: {for cooling} - A61F 2007/0086: {with a thermostat} - A61F 2007/0096: {with a thermometer} - A61M 19/00: Local anaesthesia (syringes therefor A61M5/00); Hypothermia (A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36) - A61M 60/268: the displacement member being flexible, e.g. membranes, diaphragms or bladders - A61M 60/538: Regulation using real-time blood pump operational parameter data, e.g. motor current - A61M 60/857: Implantable blood tubes - A61M 2205/3355: Controlling downstream pump pressure - A61M 2205/3368: Temperature - 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)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract Improved systems and methods for extracorporeal blood temperature control and patient temperature control, e.g., for induced hypothermia and optional normothermia, may include or otherwise employ a heat exchanger for cooling/warming of a fluid, a thermal exchange module having fluidly isolated first and second volumes, and a fluid pump for circulating the fluid through the heat exchanger and the first volume of the thermal exchange module. A blood pump may be provided for the flow of blood through the second volume of the thermal exchange module, and a first controller may be provided for providing output signals for use in operation of the heat exchanger to selectively control thermal exchange between the fluid circulated through the first volume of the thermal exchange module and the blood flowed through the second volume of the thermal exchange module, thereby providing for selective cooling/warming of the blood. A multi lumen catheter may be utilized for the flow of blood from a patient vascular system to the second volume of the thermal exchange module, and for flow of blood from the second volume of the thermal exchange module back to the patient vascular system. The circulated fluid may be optionally circulated through a patient contact pad(s) for contact cooling/warming, wherein patient cooling/warming may be provided in a first mode via blood cooling/warming in the thermal exchange module, and patient cooling/warming may be provided in a second mode via thermal exchange by the contact pad(s). ## Claims ### Claim 1 A system for extracorporeal blood temperature control, comprising: a heat exchanger for at least cooling a fluid, wherein the heat exchanger includes a circulation tank for containing the fluid; a thermal exchange module having a first volume and a second volume fluidly isolated from one another; a fluid pump fluidly interconnected to the circulation tank of the heat exchanger to circulate said fluid through said circulation tank of said heat exchanger, and fluidly interconnected to the first volume of the thermal exchange module to circulate the fluid through the first volume of the thermal exchange module, wherein operation of said fluid pump establishes a negative pressure within the first volume of said thermal exchange module so that said fluid is drawn from the circulation tank through the first volume of said thermal exchange module; a blood pump for flowing blood through a first blood flow line, said second volume of said thermal exchange module, and a second blood flow line; and, a first controller for providing output signals for use in operation of at least said heat exchanger to selectively control at least cooling of the fluid contained in the circulation tank to a desired temperature for thermal exchange between said fluid circulated through the first volume of the thermal exchange module and said blood flowed through the second volume of the thermal exchange module and thereby provide for at least selective cooling of the circulated blood. ### Claim 2 (depends on 1) The system of claim 1, wherein the circulation tank is separately fluidly interconnected to an outlet port of the fluid pump and an inlet port of the first volume of the thermal exchange module, and wherein an outlet port of the thermal exchange module is fluidly interconnected to an inlet port of the fluid pump. ### Claim 3 (depends on 1) The system of claim 1, further comprising: a first fluid temperature sensor for sensing a temperature of said circulated fluid and providing a first fluid temperature signal indicative thereof, wherein said first controller is provided to utilize said first fluid temperature signal to generate said output signals. ### Claim 4 (depends on 3) The system of claim 3, further comprising: a blood temperature sensor for sensing a temperature of said blood flowed through the second volume of the thermal exchange module and providing a blood temperature signal indicative thereof, wherein the first controller is provided to utilize said blood temperature signal to provide an output signal for use in operation of the blood pump. ### Claim 5 (depends on 3) The system of claim 3, wherein said first controller is further provided to receive a patient temperature signal indicative of a sensed patient temperature, and to utilize the patient temperature signal together with said first fluid temperature signal to generate said output signals. ### Claim 6 (depends on 1) The system of claim 1, further comprising: a multi lumen catheter fluidly interconnectable or interconnected to said first and second blood flow lines to receive said blood flowed through the second volume of the thermal exchange module from and return said blood flowed through the second volume of the thermal exchange module to a patient vascular system. ### Claim 7 (depends on 6) The system of claim 6, wherein said multi lumen catheter comprises: a catheter portion having at least a first port and a second port; a first lumen, fluidly interconnected to said first port, having an end fluidly interconnectable or interconnected to said first blood flow line; and, a second lumen, fluidly interconnected to said second port, having an end fluidly interconnectable or interconnected to said second blood flow line. ### Claim 8 (depends on 7) The system of claim 7, wherein said catheter portion of said multi lumen catheter further comprises a third port, and said multi lumen catheter further comprises: a third lumen, fluidly interconnected to said third port, having an end selectively, fluidly interconnectable to an optional component, wherein said optional component comprises a fluid source of a fluid that comprises: an anticoagulant; an anti-shivering agent; a contrast media; or a cooled fluid. ### Claim 9 (depends on 6) The system of claim 6, wherein the blood pump, the first and second blood flow lines, and the multi lumen catheter are provided to provide for blood flow through the second volume of the thermal exchange module at a blood flow rate within a range of about 50 ml/min to about 300 ml/min. ### Claim 10 (depends on 9) The system of claim 9, wherein the system is provided to circulate fluid through the first volume of the thermal exchange module at a rate that is at least about 5 times greater than the blood flow rate through the second volume of the thermal exchange module. ### Claim 11 (depends on 9) The system of claim 9, wherein the thermal exchange module is provided a heat exchange performance factor N>0.8 across a blood flow rate range of about 50 ml/min to about 300 ml/min, wherein: N=(T_bo-T_bi)/(T_cfi-T_bi); and, T_bo=temperature of blood flowing out of thermal exchange module; T_bi=temperature of blood flowing in to thermal exchange module; and, T_cfi=temperature of circulated fluid flowing in to thermal exchange module. ### Claim 12 (depends on 1) The system of claim 1, wherein said controller further comprises: a programmable processor control module for storing control data in relation to a plurality of different temperature control phases during which a temperature of the circulated fluid is controlled differently, wherein said programmable control module comprises control logic for utilizing said control data to provide said output signals. ### Claim 13 (depends on 12) The system of claim 12, wherein said heat exchanger is further provided for heating said circulated fluid contained in the circulation tank, and wherein said control data comprises: cooling control data for use by said control logic in providing said output signals to said heat exchanger to provide for said cooling of said blood in at least one of said plurality of temperature control phases; and, warming control data for use by said control logic to said heat exchanger in providing said output signals to said heat exchanger to provide for said warming of said blood in at least another of said plurality of temperature control phases. ### Claim 14 (depends on 12) The system of claim 12, further comprising: a user interface for receiving user input and providing user control signals, wherein said control logic utilizes said user control signals together with said control data to provide said output signals, and wherein said user interface is employable to modify said control data stored by said programmable control module. ### Claim 15 (depends on 14) The system of claim 14, wherein said user interface includes: a graphic display to visually present a plot of a target patient temperature adjustment rate based on said stored control data, and a plot of a sensed patient temperature in corresponding time relation to said plot of said target patient temperature adjustment rate. ### Claim 16 (depends on 15) The system of claim 15, wherein said graphic display is operable to display a plot of a sensed temperature of said circulated fluid and a sensed temperature of said blood flowed through the second volume of the thermal exchange module in corresponding time relation to said plot of said target patient temperature adjustment rate. ### Claim 17 (depends on 12) The system of claim 12, wherein said programmable control module is operable to store at least two protocols comprising corresponding, different control data, and wherein said user interface is employable by a user to select either of said two protocols for use by said programmable control module in generating said user control signals. ### Claim 18 (depends on 12) The system of claim 12, wherein said control data for a first phase of said plurality of different temperature control phases comprises at least one of a target patient temperature and a target blood temperature; and wherein said control data for a second phase of said plurality of different temperature control phases comprises a duration measure and at least one of a target patient temperature and a target blood temperature. ### Claim 19 (depends on 18) The system of claim 18, wherein said control data for said first phase of said plurality of different temperature control phases further comprises a duration measure. ### Claim 20 (depends on 18) The system of claim 18, wherein said control data for a third phase of said plurality of different temperature control phases comprises at least one of a target patient temperature and a target blood temperature.