WO2020081991A2

WO2020081991A2 - Controlling blood temperature in extracorporeal systems

Info

Publication number: WO2020081991A2
Application number: PCT/US2019/057022
Authority: WO
Inventors: Richard Helkowski; John Thomas Buckley; James D. Mazzone; Jeremy Thomas DABROWIAK
Original assignee: Zoll Circulation, Inc.
Priority date: 2018-10-19
Filing date: 2019-10-18
Publication date: 2020-04-23
Also published as: WO2020081995A3; WO2020081995A2; WO2020081991A3

Abstract

Devices, systems and methods for warming or cooling blood or other fluids as they circulate through an extracorporeal circuit.

Description

CONTROLLING BLOOD TEMPERATURE IN

EXTRACORPOREAL SYSTEMS

Claim of Priority

[0001] This application claims priority under 35 U.S.C. §119(e) to U.S. Patent Application Serial No. 62/799,731 , filed on January 31 , 2019, and to U.S. Application Serial No. 62/748,328, filed on October 19, 2018, the entire contents of each of which are hereby incorporated by reference.

Technical Field

[0002] The present disclosure relates generally to the fields of medicine and engineering and more particularly to devices, systems and methods for controlling the temperature of blood or other fluids that are being circulated through an extracorporeal system, such as a system for extracorporeal blood oxygenation, circulatory support or other treatment.

Background

[0003] Pursuant to 37 CFR 1.71 (e), this patent document contains material which is subject to copyright protection and the owner of this patent document reserves all copyright rights whatsoever.

[0004] Numerous types of extracorporeal systems are used for blood oxygenation, blood purification, circulatory support and other blood treatment. Such extracorporeal systems include, but are not limited to, extracorporeal life support (ECLS) systems such as membrane oxygenation (ECMO) systems and cardiopulmonary bypass (CPB) systems. Other extracorporeal blood treating systems include blood cleansing systems; blood warming or cooling systems; autotransfusion systems, hemofiltration systems, hemodialysis systems, aphresis systems and plasmapheresis systems.

[0005] ECMO systems are typically used to oxygenate a patient’s blood for extended periods of time (e.g., days) while CPB systems are used for relatively short periods (e.g., hours). CPB systems have traditionally been used to provide blood oxygenation and circulatory support during cardiac and aortic surgical procedures in which the heart is temporarily stopped. In ECMO, vascular access is typically achieved by inserting cannulas into peripheral blood vessels using percutaneous technique or superficial surgical cut and then advancing the cannulas to locations in the central vasculature (e.g., vena cava, right atrium, aorta). In CPB, vascular access is typically accomplished by intraoperative connection of cannulas to surgically exposed intrathoracic blood vessels.

[0006] ECMO can be performed either as venoarterial ECMO (VA-ECMO) or venovenous ECMO (W-ECMO). In VA-ECMO, deoxygenated blood is removed from a vein and the oxygenated blood is returned into an artery. In VA-ECMO the system typically pumps the blood under pressure to partially support the subject’s cardiac output while VV-ECMO generally provides extracorporeal lung assist but does not support cardiac function.

Summary

[0007] The present disclosure describes modular ECLS systems and related methods wherein a first device is positionable at an operating location on a second device. The first device may incorporate blood contacting components of the system and may be constructed of materials and in a manner that is suitable for disposal after a single use. The second device may incorporate non-blood contacting components of the system and may be constructed of materials and in a manner suitable for ongoing reuse (e.g., multiple uses). Either or both of the first and second devices may comprise a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) having the blood contacting or non-blood contacting functional components positioned thereon or therein. In some embodiments the first device may comprise a cartridge and the second device may comprise a console. One or more wall(s) or surface(s) of the first device may have connectors thereon which engage corresponding connectors on one or more wall(s) or surface(s) of the second device as the first device is placed in its operating position on the second device. In this manner a number of electrical, mechanical, fluidic and/or other connections may be made between the first device and the second device simply by placing the first device in its operating position on the second device, e.g., by engaging guides, such as rails tabs on the first or second device onto or into corresponding grooves or receptacles on the first or second device. In at least some embodiments, a tactile indication (e.g., a snap-fit) or other indicator (e.g., a light or audible tome) may indicate to a user when the first device has been properly placed in the operative position and all of the connections have been securely made.

[0008] In accordance with one aspect of the disclosure, an extracorporeal blood treatment system may comprise: i) a first device comprising a housing having positioned thereon or therein an extracorporeal blood flow path which includes a blood inlet, a blood treatment apparatus, a blood pumping apparatus, a blood outlet, blood carrying conduit and a blood heat exchange surface configured to exchange heat with blood flowing through the blood flow path; and ii) a second device comprising a housing having positioned thereon or therein electronic circuitry, a pump driving or powering apparatus, a controller and a heater/cooler useable for heating or cooling the blood heat exchange surface. Positioning the first device at an operating location on or in the second device may cause the pump driving apparatus to engage the blood pumping apparatus so as to cause blood to be pumped through the blood flow path and in physical and/or thermal contact with the blood heat exchange surface and may cause a surface of the heater/cooler to be physical and/or in thermal contact with the blood heat exchange surface so that the heater/cooler will warm or cool the blood heat exchange surface, which thereby exchanges heat with blood flowing through the blood flow path. In some embodiments, a surface of the heater/cooler may be in physical contact with the blood heat exchange surface and/or the blood may be in physical contact with the blood heat exchange surface. In some embodiments a surface of the heater/cooler and/or the heat exchange surface may comprise material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically conductive. In embodiments where such material is a metal, the metal may have a thermal conductivity in the range of 10 - 250 W/mK; where such material is a polymer, the polymer may have a thermal conductivity in the range of 0.10 - 0.60 W/mK; and where such material is a ceramic the ceramic material may have a thermal conductivity in the range of 20 - 350 W/mK. In some embodiments, a surface of the heater/cooler and the blood heat exchange surface may be separated by a thermally conductive material. The thermally conductive material may comprise a solid, liquid, gel or other suitable composition comprising thermally conductive material selected from: thermally conductive metals, thermally conductive polymers, thermally conductive ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically insulating. In some embodiments, the first and second devices may be equipped with one or more guides which interact to guide movement of the first device to the operating position. In some embodiments the system may further comprise a blood-carrying tube connected to or comprising a portion of the blood flow path, said blood- carrying tube being configured to exchange heat with blood flowing therethrough via the blood heat exchange surface or by augmenting the warming or cooling of blood that occurs at the blood heat exchange surface. In some embodiments, the first device may comprise a cartridge. In some embodiments, the second device may comprise a console. In some embodiments, the first device may snap fit to the operating position on or in the second device. Also, in some embodiments, the system may emit a visual or audible signal to indicate that the first device has been placed in the operating position on or in the second device. In some embodiments, the first device may be removed from the second device after a single use and thereafter replaced by a second first device. In some embodiments, the heater/cooler may comprise a resistance heater or a surface that is warmed by a resistance heater. In some embodiments, the heater/cooler may comprise a plate or pad. In some embodiments, all or part of the blood heat exchange surface may be located in or on the blood reservoir. In some embodiments, all or part of the blood heat exchange surface may be located in or on the blood filter. In some embodiments all or part of the blood heat exchange surface may be located upstream of the blood treatment apparatus. In some embodiments, all or part of the blood heat exchange surface may be located downstream of the blood treatment apparatus. In some embodiments, the first device may comprise or may be connected to blood- carrying tube(s) that carry blood to and or from the first device and all or part of the blood heat exchange surface may be located on such blood-carrying tube(s) and/or such blood-carrying tube(s) may be configured to exchange heat with blood flowing therethrough thereby augmenting the warming or cooling of blood that occurs at the blood heat exchange surface. In some embodiments, the system may comprise a conduit or channel for delivering warmed or cooled air to warm or cool such blood-carrying tube(s) and/or all or part of the blood flow path of the first device. In some such embodiments, a blood-carrying tube may be positioned in such conduit or channel through which the warmed or cooled air flows. In some embodiments, blood-carrying tube(s) may comprise a heat exchange fluid lumen through which a heat exchange fluid may circulate to warm or cool blood flowing through the blood- carrying tube. In some embodiments, a heat exchange jacket may be positionable on a blood-carrying tube to warm or cool blood flowing through the blood-carrying tube. In some embodiments, a blood-carrying tube may be connected to the blood inlet of the first device to deliver blood into the blood flow path of the first device. In some embodiments, a blood-carrying tube may be connected to the blood outlet of the first device to carry blood out of the blood flow path of the first device. In some embodiments, the system may further comprise a thermally insulated blood return tube connected to the blood outlet of the first device. In some embodiments, the blood treatment apparatus may comprise a blood oxygenator. In some embodiments, the blood treatment apparatus comprises an apparatus selected from: a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus. In some embodiments, the system may further comprise at least one temperature sensor. In embodiments that include at least one temperature sensor, such temperature sensor(s) may sense the temperature of blood in the blood flow path and/or within a patient and communicate the sensed blood temperature to the controller, the controller may receive input of a target blood temperature and the controller may be programmed and operative to control the temperature of the heater/cooler so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature. In some embodiments, the heater/cooler of the second device may comprise a resistance heater which warms the blood heat exchange surface when the first device is positioned at the operative location. In some embodiments, the blood heat exchange surface may be aligned with and in heat exchanging proximity to the resistance heater when the first device is positioned at said operative location. In some embodiments, the first device may comprise valving device(s) and the second device may comprise valving device actuator(s) and the act of positioning the first device at the operating location on or in the second device may cause engagement of the valving device actuator(s) with the valving device(s). In some embodiments, the first device may comprise first device electrical connector(s) and the second device may comprise second device electrical connector(s) and the act of positioning the first device at the operating location on or in the second device may cause engagement of the first device electrical connector(s) with the second device electrical connector(s). In some embodiments, the first device may comprise a plurality of sensors which is/are caused to communicate with the controller located in the second device when at least one first device electrical connector is engaged with at least one second device electrical connector. In some embodiments, all or part of the blood heat exchange surface may be located in a protrusion that extends from the first device, the heater/cooler may be useable for heating or cooling that blood heat exchange surface when it is located in such depression or cavity and, when the first device is positioned in the operating position, the protrusion may be received within the depression or cavity. In some embodiments, the depression or cavity may contain a heat exchange fluid that is warmed or cooled to cause warming or cooling of the blood heat exchange surface when the protrusion is within the depression or cavity. In some embodiments, the all of part of the blood heat exchange surface may be located in a depression or cavity in the first device, the heater/cooler useable for heating or cooling the blood heat exchange surface may be located on a protrusion that extends from the second device; and when the first device is positioned in the operating position, the protrusion on the second device may be received within the depression or cavity of the first device. In some embodiments, the depression or cavity may contain a heat exchange fluid that is warmed or cooled to cause warming or cooling of the blood heat exchange surface when the protrusion is within the depression or cavity. In some embodiments a seal, gasket or other member may be configured to limit dissipation of heat from an area around the blood heat exchange surface and/or heater/cooler when the first device is in the operating position. In some embodiments, the heater/cooler may comprise apparatus for delivering a warmed or cooled fluid or vapor to warm or cool the blood heat exchange surface when the first device is in the operating position. Such warmed or cooled fluid or vapor may, in some embodiments, be circulated through a heat exchange plate, block or other member in the second device which in turn warms or cools the blood heat exchange surface of the first device when the first device is in the operating position. Such warmed or cooled fluid or vapor may, in some embodiments, be circulated through a cavity or depression on the second device and the blood heat exchange surface is located on a protrusion from the first device, said protrusion being received within the depression of cavity when the first device is in the operating position. In some embodiments, a heat exchange plate, block or other member in the second device may warm or cool the blood heat exchange surface of the first device when the first device is in the operating position. In some embodiments, the heater cooler may comprise a bath that contains a warmed or cooled fluid and the blood heat exchange surface comprises a protrusion from first device which becomes positioned in the bath when the first device is in the operating position. In some embodiments, the blood heat exchange surface may comprise a coiled segment of blood tubing which protrudes from the first device and becomes positioned in the bath when the first device is in the operating position. In some embodiments, a coil, coiled segment of blood tubing or other protrusion may extend downwardly from a bottom of the first device and a bath may be formed in a bottom portion of the second device such that the coil, coiled segment of blood tubing or other protrusion becomes positioned in the bath when the first device is in the operating position.

[0009] In accordance with another aspect of the disclosure, an extracorporeal blood treatment system may comprise i) a first device comprising a blood flow path having a blood inlet, a blood reservoir, blood treatment apparatus, a blood filter, blood pumping apparatus, a blood heat exchanger, a first device heat exchange fluid inflow connector and a first device heat exchange fluid outflow connector and a blood outlet, ii) a second device comprising electronic circuitry, a pump driver, controller, a heat exchange fluid warming and/or cooling apparatus; a second device heat exchange fluid inflow connector and a second device heat exchange fluid outflow connector and iii) a heat exchange fluid pump apparatus. The first device may be positionable at an operating location on or in the second device such that: the pump driving apparatus engages the blood pumping apparatus so as to cause blood to be pumped through the blood flow path; the first device heat exchange fluid inflow connector engages the second device heat exchange outflow connector such that the heat exchange fluid pump may pump heat exchange fluid that has been warmed or cooled by the heat exchange fluid warming and/or cooling apparatus from the second device into the first device and through the blood heat exchanger wherein the heat exchange fluid may exchange heat with blood flowing through the blood flow path; and/or the first device heat exchange fluid outflow connector engages the second device heat exchange fluid inflow connector such that heat exchange fluid that has passed through the blood heat exchanger may circulate back through the heat exchange fluid warming and/or cooling apparatus. In some embodiments, the heat exchange fluid warming and/or cooling apparatus may comprise a heat exchanging surface that directly contacts the heat exchange fluid such that heat is exchanged through said heat exchanging surface. Such heat exchanging surface of the heat exchange fluid warming and/or cooling apparatus may comprise a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive. Such metals may have a thermal conductivity in the range of 10 - 250 W/mK. Such polymers may have a thermal conductivity in the range of 0.10 - 0.60 W/mK. Such ceramic materials may have a thermal conductivity in the range of 20 - 350 W/mK. In some embodiments, the blood heat exchanger may comprise a thermally conductive material which separates the heat exchange fluid from the patient’s blood. Such thermally conductive material may comprise a solid, liquid, gel or other suitable composition comprising a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive. Such metals may have a thermal conductivity in the range of 10 - 250 W/mK, such polymers may have a thermal conductivity in the range of 0.10 - 0.60 W/mK and such ceramics may have a thermal conductivity in the range of 20 - 350 W/mK. In some embodiments, the heat exchange fluid pump apparatus may comprise a pump located in the second device. In some embodiments, a heat exchange fluid delivery conduit and/or heat exchange fluid return conduit may be connected to the second device and the heat exchange fluid pumping apparatus may be located on the heat exchange fluid delivery conduit and/or heat exchange fluid return conduit. In some such embodiments, the heat exchange fluid pumping apparatus may comprise a gear pump face that is mounted on the heat exchange fluid delivery conduit and/or heat exchange fluid return conduit and is engageable with a gear pump drive. In some embodiments, the heat exchange fluid warming and/or cooling apparatus may comprise a heat exchange fluid reservoir having a heating and/or cooling element for heating and/or cooling heat exchange fluid within the heat exchange fluid reservoir. In some embodiments, the heat exchange fluid warming and/or cooling apparatus may comprise a heat exchange fluid reservoir having a heater which warms heat exchange fluid within the reservoir. In some such embodiments, the heater which warms heat exchange fluid within the reservoir may comprise a resistance heater. In some embodiments the system may include a heat exchange fluid delivery conduit connected to the heat exchange fluid reservoir and a heat exchange return conduit extending from the second device and the heat exchange fluid pumping apparatus may comprise a pump face that is mounted on the heat exchange fluid delivery conduit and engageable with a pump drive which drives the pump face to cause heat exchange fluid to circulate through the heat exchange fluid delivery conduit, into the heat exchange fluid reservoir where it is warmed or cooled by the heat exchange fluid warming or cooling apparatus, then out of the second device heat exchange fluid outlet connector and into the first device heat exchange fluid inflow connector, then through the blood heat exchanger, then out of the first device heat exchange fluid outflow connector and into the second device heat exchange fluid inflow connector and then through the heat exchange fluid outflow conduit. In some embodiments, the heat exchange fluid outflow conduit may be fluidly connected to the heat exchange fluid inflow conduit such that heat exchange fluid may recirculate from the heat exchange fluid outflow conduit into the heat exchange fluid inflow conduit. In some embodiments, the heat exchange fluid outflow conduit and heat exchange fluid inflow conduit may be connected to a heat exchange fluid container such that heat exchange fluid from the heat exchange fluid outflow conduit will flow into the heat exchange fluid container and then from the heat exchange fluid container back into the heat exchange fluid inflow conduit. In some embodiments, the blood treatment apparatus may comprise an apparatus selected from: a blood oxygenator; a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus. In some embodiments, the system may comprise at least one temperature sensor. In embodiments that include at least one temperature sensor, temperature sensor(s) may sense the temperature of blood in the blood flow path and/or in a patient and communicate the sensed blood temperature to the controller and the controller may receive input of a target blood temperature and may be programmed and operative to control the temperature of the heat exchange fluid warming and/or cooling apparatus so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature. In some embodiments, the blood heat exchanger may comprise a blood carrying conduit with one or more heat exchange fluid carrying conduit(s) positioned on or around the blood carrying conduit such that heat is exchanged between the heat exchange fluid and the blood. Such heat exchange fluid carrying conduit(s) may, in some embodiments, be wound around an outer surface of the blood carrying conduit. In some embodiments, the blood heat exchanger may comprise an enclosed cavity through which the heat exchange fluid circulates and a blood carrying conduit may extend through that cavity such that such that heat is exchanged between the heat exchange fluid and the blood. In some embodiments, the blood heat exchanger may comprise a jacketed blood carrying conduit which has a blood carrying lumen and a jacket through which the heat exchange fluid circulates such that heat is exchanged between the heat exchange fluid and the blood.

[0010] In accordance with another aspect of the disclosure, an extracorporeal blood treatment system may comprise: i) a cartridge comprising a housing which houses at least a portion of a blood flow path comprising a blood inlet, blood reservoir, blood treatment apparatus, blood filter, blood pumping apparatus, blood heat exchange surface, blood outlet and apparatus for warming or cooling the blood heat exchange surface and ii) a console which houses electronic circuitry, blood pump powering or driving apparatus and a controller. The cartridge may be engageable with the console such that the blood pump powering or driving apparatus powers or drives the blood pumping apparatus so as to cause blood to be pumped through the blood flow path and in physical and/or thermal contact with the blood heat exchange surface such that the blood becomes warmed or cooled by the blood heat exchange surface wherein the blood heat exchange surface is in physical and/or thermal contact with and is thereby warmed or cooled by the apparatus for warming or cooling the blood heat exchange surface and the blood becomes treated by the blood treatment apparatus. In some embodiments, the apparatus for warming or cooling the blood heat exchange surface is selected from: a resistance heater, a thermoelectric member, a conduit through which warmed or cooled heat exchange fluid is delivered. In some embodiments, the extracorporeal flow path may further comprise a blood supply conduit that carries blood to the blood inlet of the cartridge and a blood return conduit that carries blood from the blood outlet of the cartridge and in at least some such embodiments, at least a portion of the blood heat exchange surface may be located on the blood supply conduit and/or blood return conduit. In some embodiments, a portion of the blood heat exchange surface may be located on a blood supply conduit and/or blood return conduit and another portion of the blood heat exchange surface may be located on the blood flow path within the cartridge housing. In some embodiments, the entire heat exchange surface may be located on the blood flow path within the cartridge housing. In some embodiments, the entire heat exchange surface is located on a blood supply conduit and/or blood return conduit. In some embodiments, the blood treatment apparatus may comprise a blood oxygenator. In some embodiments, the blood treatment apparatus may comprise an apparatus selected from: a blood oxygenator; a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus. In some embodiments, the system may further comprise at least one temperature sensor. In embodiments that include at least one temperature sensor, temperature sensor(s) may sense the temperature of blood in the blood flow path and/or in a patient and communicate the sensed blood temperature to the controller and the controller may receive input of a target blood temperature and may be programmed and operative to control the apparatus for warming or cooling the blood heat exchange surface so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature. In some embodiments, the apparatus for warming or cooling the blood heat exchange surface may be is selected from: a resistance heater; a pad, jacket or other member incorporating a resistance heater and disposed on all or part of the blood flow path; a heated wire disposed around all or part of the blood flow path and a warming or cooling plate, block, jacket or other member disposed on all or part of the blood flow path and through which a warmed or cooled heat exchange fluid is circulated. In some embodiments, a blood heat exchange surface and/or a surface of the apparatus for warming or cooling the blood heat exchange surface may comprise a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically conductive. In some such embodiments, the metal may have a thermal conductivity in the range of 10 - 250 W/mK and the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK. In some embodiments, the blood heat exchange surface may comprise a thermally conductive material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically conductive.

[0011] In accordance with another aspect of the disclosure, an extracorporeal blood treatment system may comprise: i) a cartridge which houses at least a portion of a blood flow path comprising a blood reservoir, blood treatment apparatus, blood filter, blood pumping apparatus and a blood heat exchange surface and ii) a console which houses electronic circuitry, blood pump driving apparatus, apparatus for warming or cooling the blood heat exchange surface and a controller. The cartridge may be engageable with the console such that the blood pump powering or driving apparatus powers or drives or engages the blood pumping apparatus so as to cause blood to be pumped through the blood flow path and in physical and/or thermal contact with the blood heat exchange surface such that the blood becomes warmed or cooled by the blood heat exchange surface wherein the blood heat exchange surface is in physical and/or thermal contact with and is thereby warmed or cooled by the apparatus for warming or cooling the blood heat exchange surface and the blood becomes treated by the blood treatment apparatus. In some embodiments, the apparatus for warming or cooling the blood heat exchange surface may be selected from: a resistance heater, a thermoelectric member, a conduit through which warmed or cooled heat exchange fluid is delivered. In some embodiments, the blood treatment apparatus may comprise a blood oxygenator. In some embodiments, the blood treatment apparatus comprises an apparatus selected from: a blood oxygenator; a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus. In some embodiments the system may further comprise at least one temperature sensor. In embodiments that include at least one temperature sensor, temperature sensor(s) may sense the temperature of blood in the blood flow path and/or in a patient and communicate the sensed blood temperature to the controller and the controller may receive input of a target blood temperature and may be programmed and operative to control the apparatus for warming or cooling the blood heat exchange surface so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature. In some embodiments, the blood heat exchange surface and/or a surface of the apparatus for warming or cooling the blood heat exchange surface may comprise a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically conductive. Such metals may have a thermal conductivity in the range of 10 - 250 W/mK, such polymers may have a thermal conductivity in the range of 0.10 - 0.60 W/mK, and such ceramics may have a thermal conductivity in the range of 20 - 350 W/mK. In some embodiments, the blood heat exchange surface may comprise a thermally conductive material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

[0012] In accordance with another aspect of the disclosure, an extracorporeal blood treatment system may comprise i) a first device comprising a blood flow path having a blood inlet, a blood reservoir, blood treatment apparatus, a blood filter, blood pumping apparatus, a blood heat exchanger, a first air flow connector, at least one conduit for circulating air from the first air flow connector in heat exchange proximity to all or part of the blood flow path such that heat is exchanged between the air and blood flowing through the blood flow path, and a blood outlet and ii) a second device comprising electronic circuitry, a pump driver, controller, a second air flow connector, air warming and/or cooling apparatus and at least one conduit for over, through or in heat exchange proximity to the air warming or cooling apparatus and out of the second air flow connector. The first device may be positionable at an operating location on or in the second device such that the pump driving apparatus connects to the blood pumping apparatus so as to cause blood to be pumped through the blood flow path, the first air flow connector connects to the second air flow connector such that air which has been warmed or cooled by the heater and/or cooler apparatus will circulate through said at least one air conduit of the first device thereby warming or cooling blood flowing through the blood flow path. In some embodiments, the blood flow path may include a blood supply conduit that carries blood from a patient to the first device and said at least one conduit for circulating air from the first air flow connector in heat exchange proximity to all or part of the blood flow path comprises an air conduit configured to circulate the warmed or cooled air in heat exchange proximity to the blood supply conduit such that heat is exchanged between the warmed or cooled air and blood circulating through the blood supply conduit. In some embodiments, the blood flow path may include a blood return conduit that carries blood from the first device back to the patient and said at least one conduit for circulating air from the first air flow connector in heat exchange proximity to all or part of the blood flow path comprises an air conduit configured to circulate the warmed or cooled air in heat exchange proximity to the blood return conduit such that heat is exchanged between the warmed or cooled air and blood circulating through the blood return conduit. In some embodiments, the second device may further comprises an air intake opening through which the warming and/or cooling apparatus receives air from outside the second device and the first device may have an air exhaust opening through which air exhausts after flowing in heat exchange proximity to all or part of the blood flow path such that heat is exchanged between the air and blood flowing through the blood flow path. In some such embodiments, the system may further comprise an air recirculation conduit that connects the air exhaust opening of the first device to the air intake opening of the second device. In some embodiments, the first device may further comprise a first air recirculation connector connected to a first air recirculation conduit configured to carry air from the conduit for circulating air after the air has passed in heat exchange proximity to all or part of the blood flow path such that heat is exchanged between the air and blood flowing through the blood flow path and the second device may further comprise a second air recirculation connector and a second air recirculation conduit configured to carry air from the second air recirculation connector to an air intake of the air warming and/or cooling apparatus and placement of the first device at the operating location may cause the first air recirculation connector to become connected in the second air recirculation connector such that air will recirculate through the first air recirculation conduit, through the second air recirculation conduit and into said air intake of the air warming and/or cooling apparatus. In some embodiments, the blood heat exchange surface and/or a surface of the air warming and/or cooling apparatus may comprise a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive. Such metals may have a thermal conductivity in the range of 10 - 250 W/mK, such polymers may have a thermal conductivity in the range of 0.10 - 0.60 W/mK and such the ceramics may have a thermal conductivity in the range of 20 - 350 W/mK. In some embodiments, the blood heat exchange surface may comprise a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

[0013] Still further aspects and details of the present disclosure will be understood upon reading of the detailed description and examples set forth herebelow.

Brief Description of the Drawings

[0014] The following detailed description and examples are provided for the purpose of non-exhaustively describing some, but not necessarily all, examples or embodiments of the invention, and shall not limit the scope of the invention in any way.

[0015] Figure 1 is a diagram of one embodiment of a modular ECLS system according to the present disclosure, wherein a first device having a blood heat exchanging surface is mountable on a second device which has a heater and/or cooler for warming or cooling the blood heat exchange surface.

[0016] Figure 1A is a partial view of the system of Figure 1 showing the first device operatively engaged with the second device such that a heater and/or cooler of the second device warms or cools a blood heat exchanging surface of the first device.

[0017] Figure 1 B is an enlarged partial view of the system of Figure 1A wherein the heater and/or cooler comprises a resistance heater. [0018] Figure 1 C is an enlarged partial view of the system of Figure 1A wherein the heater and/or cooler comprises a thermoelectric plate.

[0019] Figure 1 D is an enlarged exploded view of a portion of the system of Figure 1A wherein the blood heat exchanging surface of the first device is located in or on a protrusion and the heater and/or cooler of the second device is located in or on a depression or cavity within which the heat exchanging surface is received.

[0020] Figure 1 D’ shows the protrusion of the first device positioned at an operating position within the depression or cavity of the second device.

[0021] Figure 1 E is an enlarged partial view of the system of Figure 1A wherein the blood heat exchanging surface of the first device is located in or on a protrusion and the heater and/or cooler of the second device comprises a heat exchange fluid reservoir within which the heat exchanging surface is received.

[0022] Figure 1 F shows another embodiment of the system of Figure 1 A wherein the blood heat exchanging surface of the first device comprises a blood circulating coil which extends downwardly from the first device and the heater and/or cooler of the second device comprises a bath containing warmed or cooled fluid. Figure 1 G is an enlarged partial view of the system of Figure 1A wherein the heater and/or cooler comprises a member through which a warmed or cooled heat exchange fluid circulates.

[0023] Figure 1 FI is a diagram of a system having a member through which a warmed or cooled heat exchange fluid circulates as shown in Figure 1 G, connected to a separate closed loop heater/cooler unit which provides circulation of warmed or cooled heat exchange fluid to the second device.

[0024] Figure 2 is a diagram of another embodiment of a modular ECLS system according to the present disclosure, wherein a first device having a blood heat exchanger is mountable on a second device having heat exchange fluid connectors for supplying a flow of heat exchange fluid through the blood heat exchanger.

[0025] Figure 2A is a partial view of the system of Figure 2 showing the first device operatively engaged with the second device such that the heat exchange fluid connectors are connected to the blood heat exchanger so as to circulate heat exchange fluid through the blood heat exchanger.

[0026] Figure 2B shows an embodiment of the second device of the system of Figure 2 wherein a heat exchange fluid reservoir, heater and/or cooler and heat exchange fluid pump are contained within the second device.

[0027] Figure 2C shows an embodiment of the second device of the system of Figure 2 wherein a heat exchange fluid reservoir and heater and/or cooler are located within the second device and the heat exchange fluid reservoir is connected to a heat exchange fluid container (e.g., an IV solution bag) by way of a tube that has a gear pump mounted on the tube.

[0028] Figure 2D shows an embodiment wherein the second device incorporates a heat exchange fluid circulation member disposed on a tubular portion of the blood flow path.

[0029] Figure 2D’ shows the embodiment of Figure 2D wherein the heat exchange fluid circulation member is disposed on a blood carrying conduit that connects between the patient and the first device.

[0030] Figure 2E shows a variant wherein the heat exchange fluid circulation member comprises a cylindrical jacket.

[0031] Figure 2F shows a variant wherein the heat exchange fluid circulation member comprises a tube.

[0032] Figure 3 shows a diagram of another embodiment of a modular ECLS system according to the present disclosure wherein a first device incorporates blood-contacting components as well as a heater and/or cooler device for warming or cooling blood as it circulates through the first device, such heater and/or cooler device becoming automatically connected to power and control circuity in the second device as the first device is placed in its operating position on the second device.

[0033] Figure 3A shows the system of Figure 3 with the first device positioned in an operating position on the second device.

[0034] Figure 3A’ shows the embodiment of Figure 3A wherein the heater and/or cooler device is disposed on a blood carrying conduit that connects between the patient and the first device. [0035] Figure 3B shows a variant wherein the heater and/or cooler device comprises a pad.

[0036] Figure 3C shows a variant wherein the heater and/or cooler device comprises a wire.

[0037] Figure 4 is a diagram of another embodiment of a modular ECLS system according to the present disclosure, wherein the first device includes a first air flow connector as well as air conduit(s) (e.g., duct(s)) for circulating warmed or cooled air in heat exchanging proximity to blood-carrying components of the first device and the second device has an air heater/cooler, air conduit(s) (e.g., duct(s)) and a second air flow connector which becomes connected to the first air flow connector when the first device is placed in an operating position on the second device.

[0038] Figure 4A shows the system of Figure 4 wherein air conduit(s) carry warmed or cooled air from the first air flow connector, through the first device and through a conduit (e.g., an air flow jacket) that circulates the warmed or cooled air over a blood-carrying conduit that carries blood from the patient to the first device.

[0039] Figure 4B shows an air recirculating version of the modular ECLS system of Figure 4.

[0040] Figure 4C shows an air recirculating version of the system of Figure 4A.

Detailed Description

[0041] The following detailed description and the accompanying drawings to which it refers are intended to describe some, but not necessarily all, examples or embodiments of the invention. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The contents of this detailed description and the accompanying drawings do not limit the scope of the invention in any way.

[0042] The schematic diagrams of Figures 1 through 1 H show non-limiting examples of modular ECLS systems in which a heater and/or cooler in the second device warms or cools a blood heat exchange surface in the first device.

[0043] Figures 1 and 1A generally show an embodiment of a modular ECLS system 10 which includes a first device 12 and a second device 14. The first device 12 has a blood flow path 16 through which blood circulates. The first device may include a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses at least a portion of a blood flow path 16, which includes one or more blood contacting components of the ECLS system 10. In this example, the blood flow path 16 incorporates a heat exchanging region 27 which has at least one blood heat exchange surface 26, a blood pumping apparatus 22 and a blood treatment device 20 such as an oxygenator. At least a portion of the blood flow path may include a blood carrying channel, conduit or tubing through which blood flows between the blood contacting components. In certain embodiments, the blood heat exchange surface may be thermally or physically coupled to or integrated in a wall of the blood carrying channel, conduit or tubing, or the blood heat exchange surface may be coupled to any other part of the blood flow path and/or one or more of the components or blood contacting components of the blood flow path. The second device may include a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses one or more non-blood contacting components which, in this example, includes electrical circuitry 30 which includes a controller 34, a heater and/or cooler device 36, a pump drive or pump power connector 32 and, optionally, a user interface 38 and/or temperature sensor 39. The first device 12 is positionable on or in an operating position on the second device 14, as shown in Figure 1A. Positioning the first device 12b in its operating position on the second device 14b may include inserting guides, e.g., rails or tabs, on the first or second device onto or into corresponding grooves or receptacles on the first or second device. The act of placing the first device 12 in such operating position on the second device 14, in addition to causing the coupling of the blood pumping apparatus and pump drive or pump power connector, causes the heater and/or cooler 36 to automatically thermally and/or physically couple with the blood heat exchange surface 26. Such thermal coupling results from positioning a surface of the heater and/or cooler 36 in physical and/or thermal contact with or sufficiently close to the blood heat exchange surface 26 to cause the desired warming or cooling of the blood heat exchange surface 26. This warming or cooling of the blood heat exchange surface 26 in turn causes warming or cooling of blood that flows or accumulates in the heat exchanging region 27 of the blood flow path 16, which blood is in physical and/or thermal contact with the blood heat exchange surface 26. The heater and/or cooler 36 may be in thermal contact with the blood, e.g., a surface of the heater and/or cooler 36 may be positioned relative to (e.g., in physical and/or thermal contact) the blood heat exchange surface to provide a suitable thermal conductivity between the heater and/or cooler 36 and the blood heat exchange surface 26. Examples of polymer materials having thermal conductivity k (W/mK) which may be suitable for use in forming heat transferring structures or surfaces of the heater cooler 36 or blood heat exchange surface 26 include but are not limited to polyether block amide polymers (PEBAX™) (k= 0.18-0.20 W/mK, polyethylene terephthalate (PET)(k=0.15-0.4 W/mK), polyurethane (k=0.17 to 0.25 W/(mK)) and polyethylene. (k= 0.33 - 0.52 W/mK). In at least some embodiments such polymer materials when used to form a heat exchange bag or membrane may include a wall thickness suitable for heat transfer of .001 inches to .010 inches. Alternatively, such polymer materials when used to form blood carrying or heat exchange fluid tubing or conduits may include a wall thickness of .020 inches to 0.20 inches. Examples of metals which may be suitable for use in forming heat transferring structures or surfaces of the heater cooler 36 or blood heat exchange surface 26 include but are not limited to aluminum (k= 204-249 W/mK) (for higher efficiency of heat transfer), stainless steel (k= 12-45 W/mK) and Titanium (k= 19-23 W/mK). Other thermally conductive materials, such as ceramic materials or ceramics which may offer high thermal conductivity and electrical insulation, may also be used. Examples of ceramic materials that may be usable in at least some embodiments include but are not limited to; Beryllium Oxide - 330 W/mK, Aluminum Nitride - 180 W/mK, Boron Nitride- 130 W/mK, Shapal Hi-M Soft - 90 W/mK and Alumina - 28 W/mK. Also, in some embodiments, the material may be selected on the basis of both thermal and electrical conductivity properties, e.g., materials that are thermally conductive but electrically insulating (e.g., ceramic) and/or materials that are thermally conductive and electrically conductive (e.g., metal). In certain embodiments, a metal may have a thermal conductivity in the range of 10 - 250 W/mK, the polymer material may have a thermal conductivity in the range of 0.10 - 0.60 W/mK, and the ceramic material or ceramics may have a thermal conductivity in the range of 20 - 350 W/mK. The thermal conductivity values stated for the above materials are provided as examples and may vary due to changes in temperature and other factors.

[0044] The heater/cooler 36 heat exchanging surface and the blood heat exchange surface 26 may be in physical contact to maximize heat transfer or, optionally, those surfaces may be separated by a thermally conductive material layer or membrane (e.g., including any of the above materials) or suitable liquid or gel. In at least some embodiments, there will be no air gap between those heat transferring surfaces.

[0045] In some embodiments, the controller 34 may be programmed to receive a user input target temperature via the optional user interface 38 and to control the temperature of the heat exchange surface. The optional temperature sensor(s) 39 may be positioned at a desired location to sense the temperature of blood in the blood flow path, the temperature of blood in the patient, patient body temperature, temperature of the blood heat exchange surface 26 or other desired sensing location and the controller may then control the heater and/or cooler 36 to cause the sensed temperature to be equal to or within a permissible range of the user-input target temperature.

[0046] The schematic diagrams provided in this patent application do not necessarily show all of the all functional components and features that may be included in the systems. The first and second devices 12, 14 may incorporate additional components and features beyond those shown in the drawings. For example, in some embodiments, the blood flow path 16 of the first device 12 may further include other components such as a blood reservoir, blood filter, bubble detector, bypass conduit, clamps or other valving devices (e.g., tubing compressors, tubing clamps, tubing pinchers, valves, solenoid valves, stopcocks or any other device for limiting or stopping flow through any portion of the blood flow path 16. In any embodiments disclosed herein, the first and/or second devices 12, 16 may incorporate any or all of the components and features described in any of United States Patent Nos.: 7,367,540; 7,597,546; 7,682,327; 7,846,122; 8,529,488; 8,187,214; 8,568,347;

8,951 ,220; 8,834,399; 9,821 ,109; 8,882,693; 9,844,618; 8,721 ,579;

9,808,565; 8,844,336; 9,816,966; 9,623,169, the entire disclosure of each such patent being expressly incorporated herein by reference.

[0047] In the general showing of Figures 1 and 1A, the heater and/or cooler device 36 may comprise any suitable type of device capable of warming or cooling the blood heat exchange surface 26 in the desired manner. Also, the blood heat exchange surface 26 and heater and/or cooler 36 may be shaped or configured in any way suitable to facilitate the thermal coupling and effective exchange of heat between the heater and/or cooler 36 and the blood heat exchange surface 26. Figures 1 B through 1 H show some non-limiting examples of different ways in which the heater and/or cooler device 36 and blood heat exchange surface 26 may be configured. In any of the systems described herein, it may be advantageous to minimize the width of any air gap between the blood heat exchange surface 26 and the heater and/or cooler 36 and, specifically, any air gap may be limited to 0.001 -0.005 inches or no more than 0.002 inch, or the air gap may be eliminated.

[0048] As shown in Figure 1 B, in some embodiments the heater and/or cooler may comprise a resistance heater 36a.

[0049] As shown in Figure 1 C, in some embodiments the heater and/or cooler may comprise a thermoelectric device (e.g., a Peltier) 36b.

[0050] As shown in Figure 1 D and 1 D', in some embodiments the heat exchange surface 26 may be located in or on a heat exchange region 27a that comprises a protrusion 35 that protrudes from the first device 12 and the heater and/or cooler 36 may be located in a depression or cavity 37 of the second device 14. The protrusion 35 of the first device 12 is received within the depression or cavity 37 of the second device, thereby facilitating alignment of and/or maximizing/increasing the heat exchange surface or contact area for efficient and effective heat exchange between the heater and/or cooler 36 and the blood heat exchange surface 26. An optional seal member 29, such as a gasket or elastomeric O-ring, may be included to deter leakage or dissipation of heat from an area within the depression or cavity 35 adjacent to the blood heat exchange surface 26.

[0051] As shown in Figure 1 E, in some embodiments the heat exchange surface 26 may comprise blood-contacting wall(s) of a protruding heat exchange region 27b that extends from the first device 12 and the heater and/or cooler may comprise a heat exchange fluid reservoir 36c forming a receptacle, cavity or recess within which the protruding heat exchange region 27b inserts as the first device 12 is advanced to its operating position on the second device 14. A seal member 44, such as a gasket or elastomeric O- ring, may form fluid tight seal between the outer surface of the protruding heat exchange region 27b and a wall or mouth of the heat exchange fluid reservoir 36c to deter leakage of heat exchange fluid from inside the heat exchange fluid reservoir 36c. Warmed or cooled heat exchange fluid (e.g., a liquid or vapor) is pumped through supply line 42, through the reservoir 36c and out of the return line 47.

[0052] In a variation of the example shown in Figure 1 E, the fluid reservoir may be configured as a double walled cavity or recess, the heat exchange fluid may circulate through a space between an inner wall and outer wall of that double walled cavity or recess and the outer surface of the protruding heat exchange region 27b may be in physical and/or thermal contact with the inner wall of that double walled cavity or recess. In this manner, the circulating heat exchange fluid will be contained between the inner and out wall and the seal member 44 will no longer be required to prevent leakage of the heat exchange fluid.

[0053] Figure 1 F shows an alternative embodiment wherein the blood heat exchanging surface of the first device 12a comprises a blood circulating coil 31 which extends downwardly from the bottom of the first device 12a and the heater and/or cooler of the second device 14a comprises a bath 36d containing warmed or cooled fluid. Circulation of warmed or cooled heat exchange fluid may be provided into and out of the bath 36d through lines 42, 47, as the coil sits in the bath. Alternatively, in some embodiments, the bath 36d may contain a non/flowing fixed amount of fluid (e.g., glycol) that is warmed or cooled by a warming or cooling apparatus on the bath 36d. Optionally, a protruding heat exchange region like 27b could be used in place of the coil.

[0054] As shown in Figure 1 G, in some embodiments of the system 10 the heater and/or cooler device 36 may comprise a warming or cooling member 36d (e.g., a plate or block) having channel(s) through which a warmed or cooled heat exchange fluid circulates. Warmed or cooled heat exchange fluid (e.g., a liquid or vapor) is pumped through supply line 42, through the heat exchange member 36d and out of the return line 47.

[0055] In any embodiments that require a warmed or cooled heat exchange fluid, the system may optionally include a closed loop heat exchange fluid circulation system 200, an example of which is shown in Figure 1 H. Such closed loop heat exchange fluid circulation system 200 generally comprises a heat exchange fluid container 202, heat exchange fluid supply conduit 204, heat exchange fluid return conduit 206, heat exchange fluid pumping apparatus 210 and 212 and a heater cooler device 208. The heat exchange fluid supply conduit 204 is connectable to the heat exchange fluid supply line 42 of the second device 14. The heat exchange fluid return conduit 206 is connectable to the heat exchange fluid return line 47 of the second device 14. The heat exchange fluid container 202 is positionable at an operating position on or in the heater/cooler 208 such that that the heater/cooler will warm or cool heat exchange fluid circulating through the heat exchange container 202. In the example shown, a heat exchange fluid pumping apparatus 210 (e.g., a pump impeller or peristaltic pump tube) is positioned on or in the heat exchange fluid container 202. Such pumping apparatus 210 becomes engaged with a pump driver 212 (e.g., a magnetic or mechanical driver for rotating a pump impeller of a peristaltic compressor for causing peristaltic compression of a peristaltic pump tube) located in or coupled to the heater/cooler 208 when the heat exchange container 202 is inserted in or otherwise placed in its operating position. The pumping apparatus 210 then circulates heat exchange fluid from the container 202, through supply conduit 204, through supply line 42, through warming or cooling member or heat exchange member 36D (or alternatively through a containment well 36c as in the alternative example of Figure 1 E or bath), through return line 47, through return conduit 206 and back into the heat exchange container 202. Further examples and details of the closed loop heat exchange fluid circulation system 200 are set forth in copending United States Provisional Patent Application No. 62/748,328 entitled Fleat Exchange in Extracorporeal Systems filed October 19, 2018, the entire disclosure of which is expressly incorporated herein by reference. Optionally, in some embodiments, the controller 34 may communicate by wired or wireless connection with the heater/cooler 208. As described above, such controller 34 may be programmed to receive a user input target temperature via the optional user interface 38 and to control the temperature of the heat exchange surface. The optional temperature sensor(s) 39 may be positioned at desired location(s) to sense the temperature of blood in the blood flow path and/or in the patient, patient body temperature, temperature of the blood heat exchange surface 26 or other desired sensing location and the controller may then control the temperature of the heater and/or cooler 36 and/or the speed of the rate at which the pumping apparatus circulates heat exchange fluid to cause the sensed temperature to be equal to or within a permissible range of the user- input target temperature. For example, the temperature sensor 39 can be placed in the blood flow path 16 which can include a blood flow path outside of the patient’s body or within the patient's body when the system is coupled to the patient. For example, the temperature sensor 39 can be placed in the patient’s vasculature, esophagus, rectum, or at other locations within the body for sensing the patient’s temperature. For example, the temperature sensor 39 can be placed outside of the blood flow path 16, such as on a patient’s body (e.g., on a patient’s skin or other surface).

[0056] In any of the embodiments of figures 1 -1 D', 1 G, 1 H (or in the above- referenced double-walled alternative construction of the Figure 1 H embodiment) all or part of the heat exchange region 27, 27a, 27b of the blood flow path and a surface of the heater/cooler may be in physical and/or thermal contact, e.g., in direct physical contact or separated by a thermally conductive material. Optionally, no air gap or a minimal air gap may exist between the surfaces.

[0057] Figures 2 and 2A generally show another embodiment of a modular ECLS system 10c in which blood heat exchanger or blood warmer/cooler is included in the first device 12b. The first device may include a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses at least a portion of a blood flow path 16, which includes one or more blood contacting components. In the example of Figure 2 and 2A, the first device 12b includes a blood heat exchanger 50 having a heat exchange fluid inlet connector 52 and a heat exchange fluid outlet connector 54. The second device may include a housing (e.g. , a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses one or more non-blood contacting components. In this example the second device 14b includes heat exchange fluid supply line 42 terminating in a supply connector 56 and a heat exchange fluid return line 47 terminating in a return connector 58. The fluid supply lines may include a conduit, tubing or channel through which fluid flows. The act of mounting the first device 12b at its operating position on the second device 14b causes the supply connector 56 to fluidly connect with inlet connector 52 and outlet connector 54 to fluidly connect with return connector 58 thereby allowing heat exchange fluid to pass into the blood heat exchanger 50 and into thermal contact with the blood flow path, e.g., a blood carrying conduit passing therethrough. Mounting the first device 12b in its operating position on the second device 14b may include inserting rails or tabs on the first or second device onto or into corresponding grooves or receptacles on the first or second device. Various connectors, latches or fasteners may be used to fluidly couple the heat exchange fluid supply and return lines 42, 47 with the blood heat exchanger. In the example of Figures 2 and 2A, the second device 14b includes a heat exchange fluid inlet connector 62 and heat exchange fluid outlet connector 60 for connecting the supply line 42 and return line 47 to a source of heat exchange fluid, which may comprise a closed loop heat exchange fluid circulation system 80 as described above. In some embodiments, a heat exchange fluid reservoir 64 may also be provided in the second device 14b. [0058] As shown in Figure 2B, in some embodiments a heat exchange fluid circulation system may be contained within the second device 14b, thereby eliminating need for connection of the supply and return lines 42, 47 to a separate source of heat exchange fluid. In the example of Figure 2B, a heat exchange reservoir 64a includes a heat exchange fluid containment vessel 70 having a heater and/or cooler 72. A heat exchange fluid pump 74 is positioned on the supply line 42. The controller 34 may control the heater and/or cooler 72 and or the pump 74 to control the temperature and/or circulation rate of heat exchange fluid in the same or similar manner as discussed above. In embodiments where only warming of blood is intended, the heater and/or cooler 72 may comprise a resistance heater that warms heat exchange fluid as it circulates through the heat exchange fluid vessel 70.

[0059] Figure 2C shows an alternative wherein a warming and/or cooling device 70a is located in the second device 14b and receives heat exchange fluid through heat exchange fluid inlet connector 62. The heat exchange fluid return line 47 leads to heat exchange fluid outlet connector 60. A heat exchange fluid container 80, such as an IV solution bag, is connected to a heat exchange fluid supply conduit 82 and heat exchange fluid return conduit 84. The supply conduit 82 is connected to inlet connector 62. The return conduit is connected to outlet connector 60. A pump 86, which may comprise a battery-powered or other power source gear pump, is positioned on heat exchange fluid supply conduit 82. The pump 86 circulates heat exchange fluid from container 80, though supply conduit 82, through a warming or cooling device 70a where it becomes warmed or cooler by heater and/or cooler 72, through supply line 42 and out of supply connector 56, into inlet connector 52, through the blood heat exchanger 50 in the first device 12a, out of outlet connector 54, into return connector 58, through return line 47, out of outlet connector 60, through return conduit 84 and back into the container 80. The controller 34 may control the heater and/or cooler 72 and/or the pump 86 to control the temperature and/or circulation rate of heat exchange fluid in the same or similar manner as discussed above.

[0060] Figure 2D shows an alternative wherein, rather than a discrete blood heat exchanger 50 as shown in Figure 2, the first device 12b incorporates a heat exchange member 50a, e.g., a jacket, conduit, tubing or sleeve, disposed on or around all or part of the first device’s blood flow path 16 to warm or cool blood circulating through the blood flow path 16. A heat exchange fluid inflow line 51 connects the heat exchange member 50a to inlet connector 52. A heat exchange fluid outflow line 53 connects the heat exchange fluid circulation member 50a to outlet connector 54. When mounted in its operative position on second device 14b, warmed or cooled heat exchange fluid will circulate from the second device’s supply connector 56, into inlet connector 52, through the inflow line 51 , through the heat exchange member 50a, through outflow line and out of the outlet connector 54 and into the second device’s return connector 58. The heat exchange member 50a is configured so that the heat exchange fluid circulating therethrough warms of cools blood as it flows though the blood flow path 16. In the system of Figure 2D the heat exchange fluid may be warmed or cooled by either a heater cooler device 64, 64a positioned within the second device 14b as described above or by a separate heater/cooler device, such as a closed loop heat exchange fluid circulation system 200 as referenced above, that is connected to the system.

[0061] Figure 2D' shows another alternative wherein the heat exchange member 50a is positioned outside of the first device 12b on the blood supply conduit 80 that carries blood from the patient to the first device 12b. Alternatively or additionally the heat exchange member may be position on the return conduit 81 that carries blood from the first device 12b back to the patient. In the Figure 2D' example, a heat exchange fluid supply line 82 extends from the inlet connector 52, through the first device 12b to a location on the first device 12b where it is connected to the heat exchange fluid inflow line 51 of the heat exchange member 50a and a heat exchange fluid return line 84 extends from the outlet connector 54 to a location of the first device 12b where it connects to the heat exchange fluid outflow line 53 of heat exchange member 50a. When the first device 12b is mounted in its operative position on second device 14b, warmed or cooled heat exchange fluid will circulate from the second device’s supply connector 56, into inlet connector 52, through supply line 82, through inflow line 51 , through the heat exchange member 50a, through outflow line 53, through return line 84, out of the outlet connector 54 and into the second device’s return connector 58. The heat exchange member 50a is configured so that the heat exchange fluid circulating therethrough warms of cools blood as it flows though the blood carrying conduit 80. In the system of Figure 2D' the heat exchange fluid may be warmed or cooled by either a heater cooler device 64, 64a positioned within the second device 14b as described above or a separate heater/cooler device, such as a closed loop heat exchange fluid circulation system 200 as referenced above, may be connected to the inlet connector 52 and outlet connector 54. In any of the embodiments, the heat exchange member 50a may be of any suitable size and/or configuration. Non-limiting examples of suitable configurations of the heat exchange member 50a are shown in Figures 2E and 2F.

[0062] In Figure 2E, the heat exchange member 50a-1 comprises a closed shell or jacket 55 which surrounds all or part of the first device’s blood flow path 16 and/or blood supply conduit 80 and/or blood return conduit 81. As indicated by the arrows on Figure 2E, warmed or cooled heat exchange fluid circulates through the shell or jacket 55 thereby warming or cooling wall(s) or the wall of the underlying blood flow path or conduit 16, 80 and/or 81 , which in turn warms or cools the blood flowing therethrough. The jacket 55 may be sized to provide the desired amount of blood heat exchange.

[0063] In Figure 2F, the heat exchange member 50a-2 comprises a heat exchange fluid tube 57 that is helically disposed about all or part of the first device’s blood flow path 16 and/or blood supply conduit 80 and/or blood return conduit 81. Warmed or cooled heat exchange fluid circulates through the heat exchange fluid tube 57 thereby warming or cooling wall(s) or the wall of the underlying blood flow path or conduit 16, 80 and/or 81 , which in turn warms or cools the blood flowing therethrough. The heat exchange fluid tube 57 may be sized to provide the desired amount of blood heat exchange.

[0064] Figures 3 and 3A show another embodiment of a modular ECLS system 10e wherein a first device 12c incorporates blood-contacting components as described above as well as a heater and/or cooler device 68 for warming or cooling blood as it circulates through the blood flow path 16 of the first device 12b. The first device may include a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses at least a portion of a blood flow path 16, which includes one or more blood contacting components. In embodiments where only warming of blood is desired, this heater and/or cooler device 68 may comprise a resistance heater within or on a wall of the blood flow path 16. The heater and/or cooler device 68 is connected by cable 83 to a first device power connector 70. The second device may include a housing (e.g., a frame, tray enclosure, case, cartridge or other modular structure) which supports or houses one or more non-blood contacting components. The second device 14c has a second device power connector 72. As seen in Figure 3A, placement of the first device 12c in its operating position on the second device 14c causes the first device power connector 70 to become connected to second device power connector 72, thereby supplying power to the heater and/or cooler device 68. The controller 34 may control the heater and/or cooler device 68 to control the amount of warming or cooling of blood circulating through the blood flow path 16.

[0065] Figure 3A' shows an alternative wherein the heater and/or cooler device 68 is positioned outside of the first device 12c on the blood supply conduit 80 that carries blood from the patient to the first device 12c. Alternatively or additionally the heat exchange member may be position on the return conduit 81 that carries blood from the first device 12c back to the patient. In the Figure 3A example, intermediate power cable 85 extends from the first device power connector 70, through first device 12c to a location where it connects to the cable 83 of heater and/or cooler device 68.

[0066] In any of the embodiments, the heater and/or cooler device 68 may be of any suitable size and configurations, e.g., extending the entire length or a part of the length of blood flow path 16, blood supply conduit 80, and/or blood return conduit 81. Examples of some possible configurations for the heater and/or cooler device are shown in Figures 3B and 3C.

[0067] As shown in Figure 3B, in some embodiments, the heater and/or cooler device may comprises a resistance heating pad 68a which wraps around all of part of the first device blood flow path 16, the blood supply conduit 80 and/or the blood return conduit 81.

[0068] Figure 3C shown an alternative in which the heater and/or cooler device comprises a heating wire 68b which is helically disposed about all or part of the first device blood flow path 16, blood supply conduit 80 and/or blood return conduit 81.

[0069] In certain embodiments, the heater and/or cooler device 68 may be a conduit or tubing through which warmed or cooled heat exchange fluid is delivered.

[0070] In some embodiments, a gaseous heat exchange fluid, such as warmed or cooled room air, may be used. For example, Figure 4 shows another embodiment of a modular ECLS system 10e wherein the first device 12d or cartridge includes a first air flow connector 98 as well as conduits 100, 102 and 106 which circulate warmed or cooled air from the first air flow connector 98, over blood flow path 16 and/or other blood-carrying components of the first device 12d, and then out of an exhaust opening 107. In the non-limiting example shown, air conduit 100 comprises an air delivery duct, air conduit 102 comprises a heat exchanger such as an air flow jacket, conduit or tubing through which air circulates over all or part of blood flow path 16 to exchange heat with blood flowing through blood flow path 16, and air conduit 110 comprises another duct which exhausts air that has circulated through the air flow jacket, out of an opening 107. The second device 14d has a heater and/or cooler 90, air conduits 92 and 94 and a second air flow connector 96. In the non-limiting example shown, the heater and/or cooler comprises a fan 97 and a heating and/or cooling element 99, which in some embodiments may comprise resistance heater(s). Air conduit 92 comprises a duct which extends from an air inlet opening on the second device 14d to the heater and/or cooler 90. Air conduit 94 comprises a duct which carries warmed or cooled air from the heater and/or cooler 90 to the second air flow connector 96. The first device may include a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses at least a portion of a blood flow path 106, which includes one or more blood contacting components. The second device may include a housing (e.g., a frame, tray, enclosure, case, cartridge or other modular structure) which supports or houses one or more non-blood contacting components.

[0071] In one mode of operation of the embodiment shown in Figure 4, placement of the first device in its operating position as described above causes the first and second air flow connectors 96, 98 to become connected. Fan 97 then circulates air inwardly through conduit 92 and through or in heat exchanging proximity to heating and/or cooling element 99 such that the air becomes warmed or cooled. The warmed or cooled air then continues to flow through conduit 94, through conduit 100, through conduit 102, through conduit 104 and out of opening 107. As the air circulates through conduit 102 (e.g., air flow jacket) heat is exchanged between the air and blood flowing through blood flow path 16, thereby warming or cooling the blood. The controller 34 may control the heater and/or cooler device 90 to thereby control the temperature and/or flow rate of the air, thereby controlling the amount of warming or cooling of blood circulating through the blood flow path 16.

[0072] Figure 4A shows an alternative wherein an air conduit 102a configured as a heat exchanger (e.g., an air circulation jacket) is connected to opening 107 and positioned outside of first device 12d' so as to exchange heat with blood flowing through blood supply conduit 80 which carries blood from the patient to the first device 12d'. Alternatively or additionally conduit 102a may be positioned on the return conduit 81 that carries blood from the first device 12d' back to the patient. In this alternative, conduit 106 carries warmed or cooled air from first air flow connector 98 to air outflow opening 107 and conduit 108 carries the air from opening 107 into conduit 102a. The air then circulates through conduit 102a exchanging heat with blood flowing through conduit 80. Conduit 110 comprises an exhaust duct or opening though which air that has circulated through conduit 102a may escape. Alternatively, the embodiments of Figures 4 and 4A, may be configured such that conduits 104 and 106 connect to a return conduit rather than an exhaust opening, such that the air may be recirculated and returned to the heater and/or cooler 90, and flow through conduits 102 or 102a to exchange heat with the flowing blood.

[0073] Figure 4B shows a modified version of the system 10e of Figure 4 wherein an air recirculation conduit 150 extends from the exhaust port of air conduit 102 to connector 152 on the first device 12d. Also recirculation conduit 156 extends from connector 154 on the second device 14d to the intake side of heater cooler 90 within the second device 14d. When the first device is placed in its operative position on the second device, air exiting the air conduit 102 will recirculate through conduits 150 and 156 and back into the intake side of heater/cooler 90.

[0074] Figure 4C shows a modified version of the system of Figure 4A wherein air exiting the air conduit 102a recirculates through recirculation conduit 160 and back into the inlet of heater and/or cooler 90.

[0075] It is to be appreciated that, although the invention has been described hereabove with reference to certain examples or embodiments of the invention, various additions, deletions, alterations and modifications may be made to those described examples and embodiments without departing from the intended spirit and scope of the invention. For example, any elements, steps, members, components, compositions, reactants, parts or portions of one embodiment or example may be incorporated into or used with another embodiment or example, unless otherwise specified or unless doing so would render that embodiment or example unsuitable for its intended use. Also, where the steps of a method or method have been described or listed in a particular order, the order of such steps may be changed unless otherwise specified or unless doing so would render the method or method unsuitable for its intended purpose. Additionally, the elements, steps, members, components, compositions, reactants, parts or portions of any invention or example described herein may optionally exist or be utilized in the absence or substantial absence of any other element, step, member, component, composition, reactant, part or portion unless otherwise noted. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.

Claims

Claims What is claimed is:

1. An extracorporeal blood treatment system comprising:

a first device which comprises a housing having positioned thereon or therein an extracorporeal blood flow path which includes a blood inlet, a blood treatment apparatus, a blood pumping apparatus, a blood outlet, blood carrying conduit and a blood heat exchange surface configured to exchange heat with blood flowing through the blood flow path; and

a second device which comprises; a housing having positioned thereon or therein electronic circuitry, a pump driving or powering apparatus, a controller and a heater/cooler useable for heating or cooling the blood heat exchange surface;

wherein positioning the first device at an operating location on or in the second device causes the pump driving apparatus to engage the blood pumping apparatus so as to cause blood to be pumped through the blood flow path and in physical and/or thermal contact with the blood heat exchange surface and causes a surface of the heater/cooler to be in physical and/or thermal contact with the blood heat exchange surface so that the heater/cooler will warm or cool the blood heat exchange surface, which thereby exchanges heat with blood flowing through the blood flow path.

2. The system according to claim 1 , wherein the surface of the heater/cooler is in physical contact with the blood heat exchange surface and/or the blood is in physical contact with the blood heat exchange surface.

3. The system according to claim 1 , wherein the surface of the heater/cooler and/or the heat exchange surface comprise material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically conductive.

4. The system according to claim 3, wherein the metal has a thermal conductivity in the range of 10 - 250 W/mK the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK and the ceramic has a thermal conductivity in the range of 20 - 350 W/mK.

5. The system according to claim 1 , wherein the surface of the heater/cooler and the blood heat exchange surface are separated by a thermally conductive material.

6. The system according to claim 5, wherein the thermally conductive material is selected from: thermally conductive metals, thermally conductive polymers, thermally conductive ceramics, materials that are thermally conductive but electrically insulating and materials that are thermally conductive and electrically insulating.

7. A system according to claim 1 wherein the first device comprises a cartridge.

8. A system according to claim 1 wherein the second device comprises a console.

9. A system according to claim 1 wherein the first device snap fits to the operating position on or in the second device.

10. A system comprising a according to claim 1 wherein one first device may be removed from the second device after a single use and thereafter replaced by a second first device.

11. A system according to claim 1 wherein the heater/cooler comprises a resistance heater or a surface that is warmed by a resistance heater.

12. A system according to claim 1 wherein the heater/cooler comprises a plate or pad.

13. A system according to claim 1 wherein the blood heat exchange surface is located in or on the blood reservoir.

14. A system according to claim 1 wherein the blood heat exchange surface is located in or on the blood filter.

15. A system according to claim 1 wherein the blood heat exchange surface is located upstream of the blood treatment apparatus.

16. A system according to claim 1 wherein the first and second devices are equipped with one or more guides which interact to guide movement of the first device to the operating position.

17. A system according to claim 1 further comprising a blood-carrying tube connected to or comprising a portion of the blood flow path, said blood- carrying tube being configured to exchange heat with blood flowing therethrough via the blood heat exchange surface or by augmenting the warming or cooling of blood that occurs at the blood heat exchange surface.

18. A system according to claim 17 further comprising a conduit or channel for delivering warmed or cooled air to warm or cool said blood-carrying tube, said blood-carrying tube positioned in said conduit or channel.

19. A system according to claim 17 wherein said blood-carrying tube has a heat exchange fluid lumen through which a heat exchange fluid may circulate to warm or cool blood flowing through the blood-carrying tube.

20. A system according to claim 17 further comprising a heat exchange jacket that is positionable on the blood-carrying tube to warm or cool blood flowing through the blood-carrying tube.

21. A system according to claim 17 wherein the blood-carrying tube is connected to the blood inlet of the first device to deliver blood into the blood flow path of the first device.

22. A system according to claim 17 wherein the blood-carrying tube is connected to the blood outlet of the first device to carry blood out of the blood flow path of the first device.

23. A system according to claim 1 further comprising a thermally insulated blood return tube connected to the blood outlet of the first device.

24. A system according to claim 1 wherein the blood treatment apparatus comprises a blood oxygenator.

25. A system according to claim 1 wherein the blood treatment apparatus comprises an apparatus selected from: a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus.

26. A system according to claim 1 further comprising at least one temperature sensor.

27. A system according to claim 26 wherein:

said at least one sensor senses the temperature of blood in the blood flow path and/or in a patient and communicates the sensed blood temperature to the controller; and

said controller receives input of a target blood temperature and is programmed and operative to control the temperature of the heater/cooler so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature.

28. A system according to claim 1 wherein the heater/cooler of the second device comprises a resistance heater which warms the blood heat exchange surface when the first device is positioned at said operative location.

29. A system according to claim 28 wherein the blood heat exchange surface is aligned with and in heat exchanging proximity to the resistance heater when the first device is positioned at said operative location.

30. A system according to claim 1 wherein the first device further comprises a plurality of valving devices and the second device comprises valving device actuators and the act of positioning the first device at the operating location on or in the second device further causes engagement of the valving device actuators with the valving devices.

31. A system according to claim 1 wherein the first device further comprises at least one first device electrical connector and the second device further comprises at least one second device electrical connector and wherein the act of positioning the first device at the operating location on or in the second device further causes engagement of said at least one first device electrical connector with said at least one second device electrical connector.

32. A system according to claim 31 wherein the first device further comprises a plurality of sensors which is/are caused to communicate with the controller located in the second device when said at least one first device electrical connector is engaged with said at least one second device electrical connector.

33. A system according to claim 1 wherein:

the blood heat exchange surface is located in a protrusion that extends from the first device;

the heater/cooler useable for heating or cooling the blood heat exchange surface is located in a depression or cavity on the second device; and

when the first device is positioned in the operating position, the protrusion is received within the depression or cavity.

34. A system according to claim 1 wherein:

the blood heat exchange surface is located in a depression or cavity in the first device;

the heater/cooler useable for heating or cooling the blood heat exchange surface is located on a protrusion that extends from the second device; and

35. A system according to claim 1 further comprising a seal, gasket or other member configured to limit dissipation of heat from an area around the blood heat exchange surface and heater/cooler when the first devices is in the operating position.

36. A system according to claim 1 wherein the heater/cooler comprises apparatus for delivering a warmed or cooled fluid or vapor to warm or cool the blood heat exchange surface when the first device is in the operating position.

37. A system according to claim 36 wherein the warmed or cooled fluid or vapor is circulated through a heat exchange plate, block or other member in the second device which in turn warms or cools the blood heat exchange surface of the first device when the first device is in the operating position.

38. A system according to claim 36 wherein the warmed or cooled fluid or vapor is circulated through a cavity or depression on the second device and the blood heat exchange surface is located on a protrusion from the first device, said protrusion being received within the depression of cavity when the first device is in the operating position.

39. A system according to claim 1 wherein the heat exchange plate, block or other member in the second device which in turn warms or cools the blood heat exchange surface of the first device when the first device is in the operating position.

40. A system according to claim 1 wherein the heater cooler comprises a bath that contains a warmed or cooled fluid and the blood heat exchange surface comprises a protrusion from first device which becomes positioned in the bath when the first device is in the operating position.

41. A system according claim 40 wherein the blood heat exchange surface comprises a coiled segment of blood tubing which protrudes from the first device and becomes positioned in the bath when the first device is in the operating position.

42. A system according to claim 40 or 41 wherein the coil or other protrusion extends downwardly from a bottom of the first device and the bath is formed in a bottom portion of the second device such that the coil or other protrusion becomes positioned in the bath when the first device is in the operating position.

43. An extracorporeal blood treatment system comprising:

a first device comprising a blood flow path having a blood inlet, a blood reservoir, blood treatment apparatus, a blood filter, blood pumping apparatus, a blood heat exchanger, a first device heat exchange fluid inflow connector and a first device heat exchange fluid outflow connector and a blood outlet;

a second device comprising electronic circuitry, a pump driver, controller, a heat exchange fluid warming and/or cooling apparatus; a second device heat exchange fluid inflow connector and a second device heat exchange fluid outflow connector; and

a heat exchange fluid pump apparatus;

wherein the first device is positionable at an operating location on or in the second device such that:

the pump driving apparatus engages the blood pumping apparatus so as to cause blood to be pumped through the blood flow path; the first device heat exchange fluid inflow connector engages the second device heat exchange outflow connector such that the heat exchange fluid pump may pump heat exchange fluid that has been warmed or cooled by the heat exchange fluid warming and/or cooling apparatus from the second device into the first device and through the blood heat exchanger wherein the heat exchange fluid may exchange heat with blood flowing through the blood flow path; and the first device heat exchange fluid outflow connector engages the second device heat exchange fluid inflow connector such that heat exchange fluid that has passed through the blood heat exchanger may circulate back through the heat exchange fluid warming and/or cooling apparatus.

44. The system according to claim 43, wherein the heat exchange fluid warming and/or cooling apparatus comprises a heat exchanging surface that directly contacts the heat exchange fluid such that heat is exchanged through said heat exchanging surface.

45. The system according to claim 44, wherein the heat exchanging surface of the heat exchange fluid warming and/or cooling apparatus comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

46. The system according to claim 45, wherein the metal has a thermal conductivity in the range of 10 - 250 W/mK. the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK and the ceramic has a thermal conductivity in the range of 20 - 350 W/mK.

47. The system according to claim 43, wherein the blood heat exchanger comprises a thermally conductive material which separates the heat exchange fluid from the patient’s blood.

48. The system according to claim 47, wherein the thermally conductive material comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

49. The system according to claim 48, wherein the metal has a thermal conductivity in the range of 10 - 250 W/mK. the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK and the ceramic has a thermal conductivity in the range of 20 - 350 W/mK.

50. A system according to claim 43 wherein the heat exchange fluid pump apparatus comprises a pump located in the second device.

51. A system according to claim 43 further comprising a heat exchange fluid delivery conduit connected to the second device and a heat exchange fluid return conduit connected to the second device and wherein the heat exchange fluid pumping apparatus is located on the heat exchange fluid delivery conduit.

52. A system according to claim 51 wherein the heat exchange fluid pumping apparatus comprises a gear pump face that is mounted on the heat exchange fluid delivery conduit and engageable with a gear pump drive.

53. A system according to claim 43 wherein the heat exchange fluid warming and/or cooling apparatus comprises a heat exchange fluid reservoir having a heating and/or cooling element for heating and/or cooling heat exchange fluid within the heat exchange fluid reservoir.

54. A system according to claim 43 wherein the heat exchange fluid warming and/or cooling apparatus comprises a heat exchange fluid reservoir having a heater which warms heat exchange fluid within the reservoir.

55. A system according to claim 43 wherein the heating and/or cooling element comprises a resistance heater.

56. A system according to claim 43 further comprising:

a heat exchange fluid delivery conduit connected to the heat exchange fluid reservoir; and

a heat exchange return conduit extending from the second device; and and wherein the heat exchange fluid pumping apparatus comprises a pump face that is mounted on the heat exchange fluid delivery conduit and engageable with a pump drive which drives the pump face to cause heat exchange fluid to circulate through the heat exchange fluid delivery conduit, into the heat exchange fluid reservoir where it is warmed or cooled by the heat exchange fluid warming or cooling apparatus, then out of the second device heat exchange fluid outlet connector and into the first device heat exchange fluid inflow connector, then through the blood heat exchanger, then out of the first device heat exchange fluid outflow connector and into the second device heat exchange fluid inflow connector and then through the heat exchange fluid outflow conduit.

57. A system according to claim 56 wherein the heat exchange fluid outflow conduit is fluidly connected to the heat exchange fluid inflow conduit such that heat exchange fluid may recirculate from the heat exchange fluid outflow conduit into the heat exchange fluid inflow conduit.

58. A system according to claim 56 wherein the heat exchange fluid outflow conduit and heat exchange fluid inflow conduit are connected to a heat exchange fluid container such that heat exchange fluid from the heat exchange fluid outflow conduit will flow into the heat exchange fluid container and then from the heat exchange fluid container back into the heat exchange fluid inflow conduit.

59. A system according to claim 43 wherein the blood treatment apparatus comprises an apparatus selected from: a blood oxygenator; a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus.

60. A system according to claim 43 further comprising at least one temperature sensor.

61. A system according to claim 60 wherein:

said controller receives input of a target blood temperature and is programmed and operative to control the temperature of the heat exchange fluid warming and/or cooling apparatus so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature.

62. A system according to claim 43 wherein the blood heat exchanger comprises a blood carrying conduit with one or more heat exchange fluid carrying conduit(s) positioned on or around the blood carrying conduit such that heat is exchanged between the heat exchange fluid and the blood.

63. A system according to claim 62 wherein said one or more the heat exchange fluid carrying conduit(s) is/are wound around an outer surface of the blood carrying conduit.

64. A system according to claim 43 wherein the blood heat exchanger comprises an enclosed cavity through which the heat exchange fluid circulates and a blood carrying conduit extending through said cavity such that such that heat is exchanged between the heat exchange fluid and the blood.

65. A system according to claim 43 wherein the blood heat exchanger comprises a jacketed blood carrying conduit which has a blood carrying lumen and a jacket through which the heat exchange fluid circulates such that heat is exchanged between the heat exchange fluid and the blood.

66. An extracorporeal blood treatment system comprising:

a cartridge comprising a housing which houses at least a portion of a blood flow path comprising a blood inlet, blood reservoir, blood treatment apparatus, blood filter, blood pumping apparatus, blood heat exchange surface, blood outlet and apparatus for warming or cooling the blood heat exchange surface;

a console which houses electronic circuitry, blood pump powering or driving apparatus and a controller; and

wherein the cartridge is engageable with the console such that the blood pump powering or driving apparatus powers or drives the blood pumping apparatus so as to cause blood to be pumped through the blood flow path and in physical and/or thermal contact with the blood heat exchange surface such that the blood becomes warmed or cooled by the blood heat exchange surface wherein the blood heat exchange surface is in physical and/or thermal contact with and is thereby warmed or cooled by the apparatus for warming or cooling the blood heat exchange surface and the blood becomes treated by the blood treatment apparatus.

67. A system according to claim 66 wherein the apparatus for warming or cooling the blood heat exchange surface is selected from: a resistance heater, a thermoelectric member, a conduit through which warmed or cooled heat exchange fluid is delivered.

68. A system according to claim 66 wherein the extracorporeal flow path further comprises a blood supply conduit that carries blood to the blood inlet of the cartridge and a blood return conduit that carries blood from the blood outlet of the cartridge.

69. A system according to claim 68 wherein at least a portion of the blood heat exchange surface is located on the blood supply conduit and/or blood return conduit.

70. A system according to claim 69 wherein a portion of the blood heat exchange surface is located on the blood supply conduit and/or blood return conduit and a portion of the blood heat exchange surface is located on the blood flow path within the cartridge housing.

71. A system according to claim 70 wherein the entire heat exchange surface is located on the blood flow path within the cartridge housing.

72. A system according to claim 70 wherein the entire heat exchange surface is located on the blood supply conduit and/or blood return conduit.

73. A system according to claim 66 wherein the blood treatment apparatus comprises a blood oxygenator.

74. A system according to claim 66 wherein the blood treatment apparatus comprises an apparatus selected from: a blood oxygenator; a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus.

75. A system according to claim 66 further comprising at least one temperature sensor.

76. A system according to claim 75 wherein:

said at least one sensor senses the temperature of blood in the blood flow path and/or in a patient and communicates the sensed blood temperature to the controller; and said controller receives input of a target blood temperature and is programmed and operative to control the apparatus for warming or cooling the blood heat exchange surface so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature.

77. A system according to any of claims 66 through 76 wherein the apparatus for warming or cooling the blood heat exchange surface is selected from:

a resistance heater;

a pad, jacket or other member incorporating a resistance heater and disposed on all or part of the blood flow path;

a heated wire disposed around all or part of the blood flow path;

a warming or cooling plate, block, jacket or other member disposed on all or part of the blood flow path and through which a warmed or cooled heat exchange fluid is circulated;

78. The system according to claim 66, wherein the blood heat exchange surface and/or a surface of the apparatus for warming or cooling the blood heat exchange surface comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

79. The system according to claim 78, wherein the metal has a thermal conductivity in the range of 10 - 250 W/mK, the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK, and the ceramic has a thermal conductivity in the range of 20 - 350 W/mK.

80. The system according to claim 78, wherein the blood heat exchange surface comprises a thermally conductive material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

81. An extracorporeal blood treatment system comprising:

a cartridge which houses at least a portion of a blood flow path comprising a blood reservoir, blood treatment apparatus, blood filter, blood pumping apparatus and a blood heat exchange surface;

a console which houses electronic circuitry, blood pump driving apparatus, apparatus for warming or cooling the blood heat exchange surface and a controller; and

wherein the cartridge is engageable with the console such that the blood heat exchange surface is positioned in physical and/or thermal contact with a surface of the apparatus for warming or cooling the blood heat exchange surface and the blood pump driving apparatus engages the blood pumping apparatus so as to cause blood to be pumped through the blood flow path and in physical and/or thermal contact with the blood heat exchange surface such that the blood that has been warmed or cooled by the blood heat exchange surface in the console circulates through the blood flow path of the cartridge and becomes treated by the blood treatment apparatus.

82. A system according to claim 81 wherein the apparatus for warming or cooling the blood heat exchange surface is selected from: a resistance heater, a thermoelectric member, a conduit through which warmed or cooled heat exchange fluid is delivered.

83. A system according to claim 81 wherein the blood treatment apparatus comprises a blood oxygenator.

84. A system according to claim 81 wherein the blood treatment apparatus comprises an apparatus selected from: a blood oxygenator; a membrane oxygenator; a blood cleanser; a hemodialysis apparatus; an aphresis apparatus and a plasmapheresis apparatus.

85. A system according to claim 81 further comprising at least one temperature sensor.

86. A system according to claim 85 wherein:

said at least one temperature sensor senses the temperature of blood in the blood flow path and/or in a patient and communicates the sensed blood temperature to the controller; and

said controller receives input of a target blood temperature and is programmed and operative to control the apparatus for warming or cooling the blood heat exchange surface so as to cause the sensed blood temperature to be equal to or within an acceptable range of the target blood temperature.

87. The system according to claim 81 , wherein the blood heat exchange surface and/or a surface of the apparatus for warming or cooling the blood heat exchange surface comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

88. The system according to claim 87, wherein the metal has a thermal conductivity in the range of 10 - 250 W/mK, the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK, and the ceramic has a thermal conductivity in the range of 20 - 350 W/mK.

89. The system according to claim 87, wherein the blood heat exchange surface comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

90. An extracorporeal blood treatment system comprising:

a first device comprising a blood flow path having a blood inlet, a blood reservoir, blood treatment apparatus, a blood filter, blood pumping apparatus, a blood heat exchanger, a first air flow connector, at least one conduit for circulating air from the first air flow connector in heat exchange proximity to all or part of the blood flow path such that heat is exchanged between the air and blood flowing through the blood flow path, and a blood outlet; and a second device comprising electronic circuitry, a pump driver, controller, a second air flow connector, air warming and/or cooling apparatus and at least one conduit for over, through or in heat exchange proximity to the air warming or cooling apparatus and out of the second air flow connector; wherein the first device is positionable at an operating location on or in the second device such that;

the pump driving apparatus connects to the blood pumping apparatus so as to cause blood to be pumped through the blood flow path; the first air flow connector connects to the second air flow connector such that air which has been warmed or cooled by the heater and/or cooler apparatus will circulate through said at least one air conduit of the first device thereby warming or cooling blood flowing through the blood flow path.

91. A system according to claim 90 wherein the blood flow path includes a blood supply conduit that carries blood from a patient to the first device and said at least one conduit for circulating air from the first air flow connector in heat exchange proximity to all or part of the blood flow path comprises an air conduit configured to circulate the warmed or cooled air in heat exchange proximity to the blood supply conduit such that heat is exchanged between the warmed or cooled air and blood circulating through the blood supply conduit.

92. A system according to claim 90 or 91 wherein the blood flow path includes a blood return conduit that carries blood from the first device back to the patient and said at least one conduit for circulating air from the first air flow connector in heat exchange proximity to all or part of the blood flow path comprises an air conduit configured to circulate the warmed or cooled air in heat exchange proximity to the blood return conduit such that heat is exchanged between the warmed or cooled air and blood circulating through the blood return conduit.

93. A system according to claim 90 wherein the second device further comprises an air intake opening through which the warming and/or cooling apparatus receives air from outside the second device.

94. A system according to claim 93 wherein the first device has an air exhaust opening through which air exhausts after flowing in heat exchange proximity to all or part of the blood flow path such that heat is exchanged between the air and blood flowing through the blood flow path.

95. A system according to claim 94 further comprising an air recirculation conduit that connects the air exhaust opening of the first device to the air intake opening of the second device.

96. A system according to claim 90 wherein:

the first device further comprises a first air recirculation connector connected to a first air recirculation conduit configured to carry air from the conduit for circulating air after the air has passed in heat exchange proximity to all or part of the blood flow path such that heat is exchanged between the air and blood flowing through the blood flow path; and

the second device further comprises a second air recirculation connector and a second air recirculation conduit configured to carry air from the second air recirculation connector to an air intake of the air warming and/or cooling apparatus;

wherein placement of the first device at said operating location further causes the first air recirculation connector to become connected in the second air recirculation connector such that air will recirculate through the first air recirculation conduit, through the second air recirculation conduit and into said air intake of the air warming and/or cooling apparatus.

97. The system according to claim 90, wherein the blood heat exchange surface and/or a surface of the air warming and/or cooling apparatus comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.

98. The system according to claim 97, wherein the metal has a thermal conductivity in the range of 10 - 250 W/mK, the polymer has a thermal conductivity in the range of 0.10 - 0.60 W/mK, and the ceramic has a thermal conductivity in the range of 20 - 350 W/mK.

99. The system according to claim 97, wherein the blood heat exchange surface comprises a material selected from: metals, polymers, ceramics, materials that are thermally conductive but electrically insulating and material that are thermally conductive and electrically conductive.