Control systems and methods of heat exchange

Abstract

Heating and cooling modules and related control systems configured for control of the temperature of a heat-exchange material are described. For example, heating and cooling modules as described herein may be used in various medical systems involving temperature regulation and heat exchange, including, for example, extracorporeal membrane oxygenation (ECMO) systems and related fluid handling systems such as heart-lung machines and related systems which may be used in cardiopulmonary bypass applications.

Description

IN THE UNITED STATES RECEIVING OFFICEINTERNATIONAL PCT APPLICATION FOR PATENTTITLE:CONTROL SYSTEMS AND METHODS OF HEAT EXCHANGEBradford James AndersonCitizenship: United StatesLinda Elias Sousse Citizenship: United States and LebanonJeffrey David DellaVolpeCitizenship: United StatesJonathan William DayCitizenship: United StatesJoshua Beltran Citizenship: United StatesAttorney Docket No.: 16059.10Applicant:Institute of ECMO Development, LLCCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Patent Application No. 63 / 524,532 titled “Control Systems and Methods of Heat Exchange” filed June 30, 2023. The full disclosure of the aforementioned patent application is herein fully incorporated by reference.FIELD

[0002] This disclosure relates to heating and cooling modules and to the use of heating and cooling modules and related control systems for use in medical applications involving heat exchange, including, for example, extracorporeal fluid handling systems.BACKGROUND

[0003] Extracorporeal fluid handling systems, such as blood oxygenators, commonly include or are used with a heat exchange system. The heat exchange system may, for example, be used to regulate the temperature of extracorporeally circulated blood to a clinically mandated temperature prior to entering or re-entering a patient’s body. A heating and cooling module and associated control system may be used to control the temperature of a heatexchange fluid that is routed through the heat exchange system so that the heat-exchange fluid may add or remove an appropriate amount of heat from the patient’s blood so as to control blood temperature.

[0004] Proper regulation of blood temperature may, for example, reduce risk of hypothermic sequela, including electrolyte imbalances, hemodynamic instability, bradycardia, or other conditions. Unfortunately, current heating and cooling systems in clinical use are generally cumbersome, heavy (—50 lbs), require large amounts of power, and require a relatively large amount of working fluid, such as water, during operation. These systems generally require plug-in accessibility to an electrical grid (AC power) and are ill suited for use in portable applications. Moreover, such systems typically operate with one or more openworking fluid tanks that are not isolated from the outside environment and which require routine disinfection and cleaning.

[0005] There is a need for improved heating and cooling modules and related temperature control systems for use in extracorporeal fluid handling systems, including, for example, those used in portable applications. There is also a need for improved heating and cooling modules and related control systems configured to minimize risk of contamination of surrounding environments and / or target fluids heated or cooled thereby. There is also a need for improved heating and cooling modules and related temperature control systems configured for ease of replacement of disposable system components.SUMMARY

[0006] Systems described herein may be directed towards solving the aforementioned problems or other problems. For example, in some embodiments, temperature control systems described herein may provide a sealed circulation system that is substantially isolated from the outside environment during operation. For example, parts of the control system that come into working contact with working fluid (sometimes referred to herein as a heat exchange fluid) (e.g., water) may be disposable. Those parts may further be used in connection with nondisposable system parts. For example, some disposable conduits (e.g., working fluid conduit piping used for heat exchange) may be mounted in a non-disposable temperature-exchange tray. The disposable conduits may be configured for ease of replacement after one or more uses or between patients. The mechanism of mounting may further facilitate effective heat exchange between the disposable conduits and the temperature-exchange tray.

[0007] In some embodiments, a disposable pump head including a pump housing and a pump impeller may be disposed in a pathway of sealed fluid communication of a temperature control system. The pump head may be removably mounted to a pump body. When the pump head is engaged with the pump body, the pump impeller may be operatively engaged with apump shaft and motor. In this configuration, a disposable pump head may be removed, and a new pump head installed and configured for use.

[0008] In some embodiments, a control system for regulating the temperature of a heatexchange fluid may be provided as a compact, portable system. The control system may be configured to operate for extended periods of time without access to electrical grid power (e.g., under battery- or solar- powered operation). In some embodiments, a portable control system may comprise a temperature-exchange tray for removable mounting of a disposable heatexchange conduit. The temperature-exchange tray may, for example, include cut-outs or grooves and latches for holding the heat-exchange conduit. The temperature-exchange tray may or may not be disposable. The temperature-exchange tray may be mounted in a heating and cooling module in a heat exchange relationship with a heating element (e.g., a resistive heater) and a cooling element (e.g., a thermoelectric semiconductor element) configured for alternative heating and / or cooling.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Fig. 1 is a schematic diagram of a first embodiment of an extracorporeal fluid handling system.

[0010] Fig. 2 is a schematic diagram of a second embodiment of an extracorporeal fluid handling system.

[0011] Fig. 3 is a schematic diagram of a third embodiment of an extracorporeal fluid handling system.

[0012] Fig. 4 is a perspective view of an exemplary embodiment of a heating and cooling module.

[0013] Fig. 5 is a top plan view of the heating and cooling module shown in Fig. 4.

[0014] Fig. 6 is a bottom plan view of the heating and cooling module shown in Fig. 4.

[0015] Fig. 7 is a side view of the heating and cooling module shown in Fig. 4.

[0016] Fig. 8 shows a cross-sectional view of an embodiment of pump including a disposable pump head coupled with a non-disposable pump body.

[0017] Fig. 9 shows a second cross-sectional view of the pump shown in Fig. 8.

[0018] Fig. 10 shows an exemplary embodiment of a heating element including a resistor sandwiched between two electrically insulating layers.

[0019] Fig. 11 is a perspective view of an embodiment of a temperature-exchange tray.

[0020] Fig. 12 is a side view of the temperature-exchange tray shown in Fig. 11.

[0021] Fig. 13 is a top plan view of the temperature-exchange tray shown in Fig. 11.

[0022] Fig. 14 is a top side plan view of an embodiment of a disposable working fluid conduit.

[0023] Fig. 15 is a perspective view of the disposable working fluid conduit shown in Fig.14.

[0024] Fig. 16 is a side view of the disposable conduit shown in Fig.14.

[0025] Fig. 17 is a perspective view of an embodiment of a thermoelectric semiconductor unit.

[0026] Fig. 18 is a top plan view of the thermoelectric semiconductor unit shown in Fig. 17.

[0027] Fig. 19 is a side view of the thermoelectric semiconductor unit shown in Fig. 17.

[0028] Fig. 20 is another side view of the thermoelectric semiconductor unit shown in Fig. 17.

[0029] Fig. 21 is a schematic view of one embodiment of a priming system.

[0030] Fig. 22 shows an embodiment of a heating and cooling module sized for portable applications.

[0031] Fig. 23 shows a second view of the heating and cooling module shown inFig. 22.

[0032] Fig. 24 shows a third view of the heating and cooling module shown in Fig. 22.

[0033] Fig. 25 is a side view of an embodiment of a temperature control system showing the system with a drawer holding a temperature exchange tray positioned in a closed position.

[0034] Fig. 26 is a perspective view of the control system shown in Fig. 25 and with the drawer positioned in an open position.

[0035] Fig. 27 is a side view of a disposable component assembly.

[0036] Fig. 28 is a side view of an embodiment of a pump head mounted to a pump body.

[0037] Fig. 29 is a top plan view of a drawer slider.

[0038] Fig. 30 is a top plan view of another exemplary embodiment of a temperatureexchange tray.

[0039] Fig. 31 is a top side plan view of another exemplary embodiment of a disposable conduit.

[0040] Fig. 32 shows an exemplary embodiment of a connector.

[0041] Fig. 33 shows the different parts of the connector of Fig. 32.

[0042] Fig. 34 shows an exemplary embodiment of a pump including a removable pump head and a pump body.DETAILED DESCRIPTION

[0043] This disclosure is directed to heating and cooling modules and related temperature control systems configured for control of the temperature of a working material. This disclosure is further directed to systems including heating and cooling modules and their applications in medicine. For example, heating and cooling modules as described herein maybe used in various medical systems involving temperature regulation and heat exchange, including, for example, extracorporeal membrane oxygenation (ECMO) systems and related body fluid handling systems such as heart-lung machines and related systems which may be used in cardiopulmonary bypass applications, and / or disease processes such as procedures in the operating room, heat stroke, drowning, and / or frostbite. In some embodiments, heating and cooling modules may be included in systems configured for extracorporeal blood exchange or blood purification, such as may be applied in renal replacement or other therapies.

[0044] In some embodiments, the control systems described herein may be used for circulation and temperature control of a heat-exchange material or working fluid, such as water. A working fluid material may, for example, be circulated for heat exchange with a patient’ s blood in a blood oxygenator. In other embodiments, a first working fluid may be used for regulation of the temperature of a second working fluid which may then be circulated for heat exchange with a patient’ s blood or other target body fluid. Thus, in some embodiments, control systems as described herein may be used, directly or indirectly, to regulate the temperature of a target fluid.

[0045] In some embodiments, a heating and cooling module or related control system may be configured so that it may regulate the temperature of a heat-exchange material and circulate the heat-exchange material in a closed or hermetically sealed fluid pathway so as to reduce risk of contamination of surrounding work areas and / or target fluids positioned in a heat exchange relationship therewith. This may, for example, be contrasted with some other systems known in the art which include tanks or other fluid components that are not closed to the environment and require routine cleaning with chemical and sanitation products. In some embodiments, heating and cooling modules or control systems as described herein may include disposable components or parts so that heat-exchange material circulating therein may be fully isolated from both the surrounding environment and any non-disposable components. In someembodiments, one or more of the disposable parts of a control system may be mounted in a non-disposable part or system component so that the disposable parts of the system may be easily, and cost efficiently removed for disposal and replacement.

[0046] For example, in some embodiments, one or more disposable conduits may be mounted within a heating and cooling module using a temperature-exchange tray. The temperature exchange tray may, for example, be mounted within the heating and cooling module using drawer sliders or rails so that the temperature-exchange tray may be readily accessed internally or externally thereby allowing for easy removal of disposable conduits (e.g., piping) disposed therein. In some embodiments, a temperature-exchange tray may be mounted within a heating and cooling module using a latching mechanism. In some embodiments, the temperature-exchange tray may comprise a cartridge that may be slidably engaged in a housing or casing of a heating and cooling module. In this context, the one or more disposable conduits may be configured for use only once or some other limited number of times before they are replaced. In contrast, the temperature-exchange tray (or other non-disposable parts of a control system) may be non-disposable in that in the absence of damage (e.g., in normal operation), the temperature control tray may be used repeatedly.

[0047] The temperature-exchange tray may be mounted in a heat-exchange relationship with at least one heating element and at least one cooling element. For example, in some embodiments, the temperature-exchange tray may be positioned in a heat exchange relationship with a heating element. The heating element may, for example, be a resistive heating element including a resistive material (e.g., a nickel chromium alloy, a copper nickel alloy, or other suitable metal alloy) mounted in an insulator (e.g., a silicone rubber insulator). The temperature-exchange tray may further be positioned in a heat exchange relationship with a thermoelectric semiconductor unit. In some embodiments, the thermoelectric semiconductor unit may be capable of alternative heating or cooling of the temperature-exchange tray and adisposable conduit positioned therein. For example, in operation the thermoelectric semiconductor unit may include a semiconductor array which, when connected to a DC voltage, produces a cold side and a hot side. In some embodiments, the orientation of the applied voltage may be changed. Accordingly, the unit may be operated so that the side of the device oriented towards the temperature-exchange tray may either absorb or provide heat. In some embodiments, the temperature-exchange tray may be mounted in a heat-exchange relationship with at least one heating element and a heater / cooler device capable of heating or cooling the tray.

[0048] A microcontroller or computer may be configured for controlling operation of the heating element and the cooling element (or heating / cooling element, as may be configured in some embodiments). For example, in some embodiments, a microcontroller may be configured to receive data from one or more sensors (e.g., temperature sensors, heat flow sensors, flow sensors, battery power or voltage sensors) and also may be configured to receive (or programmed with) other information (e.g., a set temperature or temperature range and set of instructions for operation). The microcontroller or computer may be configured to use the available data so as to control the system. For example, the microcontroller or computer may be configured to adjust one or more of the temperature, flow rate, or relative contribution of heating provided by heating elements or semiconductor heater / cooler elements during system operation. Some embodiments herein may be ideally configured for rapid heating or cooling and efficient buffering of the temperature of a circulating heat exchange fluid without requiring large volumes of heat-exchange fluid. Accordingly, some embodiment herein may be ideally configured for portable and low power consumption applications. More generally, although some embodiments herein are not limited to portable or related applications, systems herein may generally provide a considerably reduced footprint and weight as compared to some other systems in the prior art.

[0049] In some embodiments, a first disposable part of a pump (e.g., a disposable pump head) may be mounted in a second non-disposable part of a pump. A disposable pump head including a disposable housing may, for example, be configured to couple with a nondisposable pump body. When the disposable pump head and non-disposable pump body are coupled, the pump head may receive a pump shaft connected to a motor. The disposable pump head may further include an impeller that may be operably engaged with the shaft when the pump head is coupled or engaged with the pump body. Heat-exchange fluid may be pumped through the pump head without directly contacting the pump shaft or motor or other non- disposable parts of the pump. The disposable pump head may be disengaged from the pump body and discarded and replaced with a sterile disposable pump head (e.g., after a single use or limited number of uses) whereas the pump body (e.g., rotor and pump) may be kept for further use.

[0050] An exemplary embodiment of an extracorporeal fluid handling system 10 including a control system 12 for controlling the temperature of a heat-exchange material is shown in Fig. 1. The control system 12 may, for example, be coupled to a target device 22 and used to circulate the heat-exchange material along a sealed fluid pathway placed in a heat exchange relationship with blood or another fluid. The heat-exchange material may, for example, comprise a heat-exchange fluid such as water. Of course, other suitable heatexchange fluids may also be used. For example, in some embodiments, the heat-exchange material may comprise glass beads or another solid or a suspended material which may be provided in a carrier fluid. Heat-exchange material may, for example, be used directly or indirectly to control the temperature of blood or another fluid circulated through a target device such as a membrane blood oxygenator, for example.

[0051] In some embodiments, as shown in Fig. 1, a control system 12 may include a heating and cooling module 14 and a pump 32. Heating and cooling module 14 may includeor be engageable with one or more conduits 19 (e.g., pipe sections shown as a dashed line in Fig. 1) mounted or extending therein, as may be used to circulate heat-exchange material through the heating and cooling module. One or more additional conduits 16 may also be included as may be used, for example, to connect heating and cooling module 14 with the pump 32, and / or to connect other components of the control system 12. Generally, the conduits 16, 19 may be the same or differently composed. For example, the conduits 19 may be comprised of a material suitable for both sealed fluid communication of heat-exchange material and conduction of heat when mounted in the heating and cooling module 14. The conduits 16 may be configured for sealed fluid communication of heat-exchange material.

[0052] Other embodiments of control systems 120, 220 are shown in Fig. 2 and Fig. 3. As shown in Fig. 2, an extracorporeal fluid handling system 100 may include a control system 120 including one or more disposable reservoirs 30. The disposable reservoirs 30 may, for example, be used for storing or conditioning a heat-exchange material and for priming of the system when removing air from the system 100. In some embodiments, as shown in Fig. 3, an extracorporeal fluid handling system 200 may include a control system 220 including a secondary heat exchanger 15. For example, a first heat-exchange material may be circulated through the first conduit system 16. The first conduit system 16 may be positioned in a heat exchange relationship with a second conduit system 17 so that the temperature of a second heat-exchange material circulated therethrough may be controlled. This second heat exchange material may then be used for heat exchange with fluid (e.g., blood or another intermediate exchange fluid) circulating in a target device 22. Thus, a first heat-exchange material may be configured in a direct heat exchange relationship with the target device 22 (as shown in Fig. 1 and Fig. 2). Alternatively, as shown in Fig. 3, a first heat-exchange material may control heat exchange with one or more other materials which may then be used for heating or cooling the target fluid (e.g., blood) such as through one or more additional heat exchangers.

[0053] Other components which may be present in some embodiments of control systems 12, 120, 220, include, for example, flow sensors, temperature sensors, pressure sensors, vibration sensors, other sensors, flow control valves, check valves, shut-off valves, valve actuators, and other components such as may be useful for regulation or control of one or more of a temperature, flow rate, and direction of a heat-exchange material. In some embodiments, a microcontroller or computer 27 may be part of a control system 12, 120, 220. The microcontroller or computer 27 may, for example, be operatively connected with components of a control system 12, 120, 220, such as by wired or wireless means. A microcontroller or computer 27 may be programmed with or configured for receiving instructions for controlling the operation of various systems components of a control system 12, 120, 220. A microcontroller or computer 27 may further be configured for outputting diagnostic information or other information associated with a control system 12, 120, 220. In some embodiments, a computer 27 may be configured for executing one or more algorithms for adjusting operation of the various components of a system 12, 120, 220. In some embodiments, a battery 29 may be provided for at least short-term portability. For example, the system may be configured to operate using an AC power source but revert to using low voltage direct current from a battery when unplugged from wall power. In some embodiments, a system 12, 120, 220 may operate using both AC and DC power at the same time. Such an operational mode may, for example, be engaged so as to decrease a time to get to a target or set temperature, or to charge a rechargeable battery. In some embodiments, relays may be used to control operation or use of AC and DC power sources. In some embodiments, a control system 12, 120, 220 may regulate the temperature of a heat-exchange material using an algorithm that depends on whether an AC power source is available and / or if only the battery 29 is available for powering the system or available at a certain power level. In some embodiments, the control system may include a low-power mode that operates heating orcooling elements on a different timing, fluid flow and temperature cycle than a normal-power mode. For example, in some embodiments, it may be useful to use only one of a resistive heating element or heater / cooler element when heating a heat-exchange material. In other situations, depending, for example, on available power resources, heating may be accomplished using both a resistive heating element and heater / cooler element. Systems 12, 120, 220 as described herein may be configured for low power consumption, a characteristic which facilitates ease of use and portability. For example, in some embodiments, a system may use no more than about 1,200 watts of energy and weigh no more than about 25 pounds (11.3 kgs).

[0054] As shown in each of the control systems 12, 120, 220 (shown in Figs. 1-3), a conduit system may include a fluid outlet port 18 and a fluid inlet port 20. The ports 18, 20 may be removably coupled to corresponding ports 24, 26 of a target device 22 so that heatexchange material (e.g., material at a target temperature and / or flow rate) may be circulated though the target device. Any of various suitable fluid-tight couplings or fittings (e.g., Swagelok brand for luer lock fittings) may be used to connect the ports 18, 20, with the ports 24, 26 as known in the art. Couplings for fittings may, for example, be connected to conduits 16 (as shown in Fig. 1, for example). Alternatively, one or more of the ports 18, 20 may be provided directly by conduits 19 (e.g., conductive piping designed for heat exchange in heating and cooling module 14), as shown, for example, in Fig. 2. Target device 22 may, for example, comprise a blood oxygenator, heart lung machine, or other device configured for extracorporeal handling of a target fluid. For example, in the illustrated embodiment, the target device 22 is a blood oxygenator so that fluid pumped therethrough is blood.

[0055] Target device 22 may include one or more pumps 28 and / or sensors (not shown) for control and regulation of fluid or blood flow. For example, blood may enter the target device 22 through an inlet (e.g., a port connected to a cannula, commonly inserted into a patient’s vein) and exit the target device though an outlet. For example, in some embodiments,the inlet of the target device may be a port coupled to a cannula inserted into one of the patient’ s vasculature. Following membrane oxygenation and heat exchange, blood may reenter the patient’s body via the target device outlet. For example, the outlet may be coupled to a second cannula inserted into an artery of the patient.

[0056] In some embodiments, a control system 12, 120, 220, 400 may be a closed system configured for operation without open containers which, if present, may increase the risk of contamination of surrounding work areas (e.g., commonly an operating room) or risk of contamination of the target device 22 and any material or fluid circulating therethrough. For example, a control system 12, 120, 220, 400 housing may be hermetically sealed and include a separately sealed fluid tight working fluid circulation system. In some embodiments, this fluid circulation system may include the entire pathway of material flow (e.g., the fluid flow pathway extending from the inlet port 20 to the outlet port 18) through a control system 12, 120, 220, 400. For example, the entire fluid circulation system may be comprised of disposable conduits, disposable reservoirs, or related disposable structures or pathways through which heatexchange material may flow.

[0057] For example, as shown in Fig. 1, fluid circulation system 21 may include one or more conduits 19 or both conduit systems 16, 19 (if, for example, additional conduits 16 are present). The fluid circulation system 21 may further include one or more channels or material pathways extending through a pump 32. For example, as shown in Fig. 8 and Fig. 9, in some embodiments, the pump 32 may include a disposable pump head 62 including a disposable housing 68. For example, an inlet (I) and an outlet (O) may be formed within or coupled to the disposable housing 68 so that heat-exchange material does not come into contact with any nondisposable surface when circulating through the pump 132. The disposable pump head 62 may be configured for coupling to a non-disposable pump body 66. Thus, the disposable pumphousing 68 may form a part of the fluid circulation system 21 and comprise a disposable cavity or channel through which heat-exchange material may circulate.

[0058] In some embodiments, as shown in Fig. 2, a fluid circulation system 23 may include the conduit systems 16, 19 together with either or both of an at least in part disposable pump 32 (e.g., as may include disposable pump head 62) and a disposable fluid reservoir 30. In some embodiments, substantially the entire fluid circulation system (e.g., all components of the control system 120 that come into direct physical contact with circulating heat-exchange material) may be disposable.

[0059] In some embodiments, as shown in Fig. 3, a fluid circulation system 25 may include the conduit systems 16, 19 together with one or more of a disposable head 62 of a pump 32, a disposable fluid reservoir 30, and a disposable secondary fluid exchange system 15. In some embodiments, substantially the entire fluid circulation system (e.g., all components of the control system 220 that come into direct and substantial physical contact with circulating heat-exchange material) may be disposable.

[0060] In some embodiments, at least some of the components of control system 12, 120, 220, 400 that come into direct and substantial physical contact with circulating heatexchange fluid may be disposable. For example, all of the components or component parts that come into direct and substantial contact with circulating heat-exchange fluid may he disposed after a single use or after some other number of uses. In some embodiments, any given means for tracking a number of uses (e.g., a single use or limited number of uses) of a component or component part of a control system 12, 120, 220, 400 that may come into physical contact with circulating heat-exchange fluid may be used. For example, in some embodiments, an RFID tag may be scanned each time a system 12, 20, 220, 400 is used so that a number of uses of one or more disposable components or component parts of the system 12, 20, 220, 400 may be tracked or recorded. A warning or alarm may then be provided (e.g., using a display screen ofor in communication with the microcontroller 27) whenever a user attempts to use the system before one or more disposable components is replaced. In some embodiments, a system for tracking the use of disposable system components or component parts may include a sensor (e.g., a fluid detection or flow sensor) configured to detect a first or subsequent use of a given system component. For example, any combination of a sensor, fluid level sensor, fluid flow sensor, RFID tag or other suitable means may be used for tracking a number of uses of one or more disposable components or component parts of a control system 12, 20, 220, 400. Thus, in some embodiments, a control system 12, 120, 220, 400 may be configured to automatically track use of at least some of its components or component parts. Embodiments in which heatexchange material is circulated in a control system 12, 120, 220, 400 only in contact with disposable system components may be contrasted with some other extracorporeal fluid handling or related systems in the prior art in which only secondary fluid exchange components (e.g., those indirectly positioned in contact with heater / coolers) are disposable or in which only a portion of the associated conduit tubing of a control system is disposable.

[0061] An exemplary embodiment of a heating and cooling module 40 is shown in Figs. 4-7. The heating and cooling module 40 may, for example, be integrated into any of the control systems 12, 120, 220 shown in Figs. 1 -3. For example, the heating and cooling module 14 (as shown in any of Figs. 1 -3) may be replaced with the heating and cooling module 40 as shown in Fig. 4-7. Likewise, the one or more conduits 19 (as shown in any of Figs. 1-3) may be replaced with a disposable conduit 48 (also shown in Figs. 14-16, for example). In some embodiments, as shown, for example, in Figs. 22-24, the heating and cooling module 40 may be sized for portable applications. The dimensions shown in Figs. 22- 24 are given in inches unless otherwise noted. For example, the dimensions shown therein include L24 at about 4.7 inches (11.8 cm). Other dimensions shown therein include L25 (17.8 cm), L26 (13.4 cm), and L27 (17.4 cm).

[0062] As shown in Figs. 4-7, heating and cooling module 40 may, in some embodiments, include a temperature-exchange tray 42, a thermoelectric semiconductor unit 44, and a heating element 46. In some embodiments, the temperature exchange tray 42 may be mounted within the heating and cooling module using drawer sliders or rails 47 so that the temperature-exchange tray may be readily accessed thereby allowing for easy removal of disposable conduits (e.g., piping) disposed therein. For example, in some embodiments, a pair of drawer slides or rails 47 may be used to slidably position the temperature-exchange tray 42 in engagement with the thermoelectric semiconductor unit 44. The thermoelectric semiconductor unit 44 and the heating element 46 may be mounted on opposite side of the temperature-exchange tray 42. An exemplary embodiment of the heating element 46 is also shown in Fig. 10. Heating element 46 produces heat that may be transferred into temperatureexchange tray 42 and disposable conduit 48 to heat heat-exchange material flowing therethrough. In some embodiments, the heating element 46 may be comprised of a resistive material (e.g., a relatively high resistance metal) surrounded by an insulating material. For example, a relatively high resistance metal may be formed as a serpentine shaped resistor 82 (e.g., a metal wire or band). The resistor 82 may be sandwiched between the insulating layers 84, 86. In some embodiments, resistor 82 may be comprised of a nickel chromium alloy, a copper nickel alloy, or other suitable metal alloy. In some embodiments, the insulating material may be comprised of a high silicon content rubber.

[0063] In some embodiments, heating element 46 may be placed in direct contact with the temperature-exchange tray 42. In some embodiments, a suitable glue, epoxy, or other binding agent may be used to ensure suitable thermal contact between the heating element 46 and the temperature-exchange tray 42. Alternatively, the heating element 46 may be held against the temperature-exchange tray 42. For example, the heating element 46 may be held against the temperature-exchange tray 42 by containing it between the temperature-exchangetray 42 and an outer housing or casing of the heating and cooling module 40. In some embodiments, the insulating material may be compressible so that it expands against the temperature-exchange tray 42 when mounted under compression (e.g., when sandwich between the temperature-exchange tray 42 and an outer housing or casing of the heating and cooling module 40). In some embodiments, heating element 46 may operate over a temperature range of about 56° C to about 232° C, or over some other suitable temperature range.

[0064] An exemplary embodiment of thermoelectric semiconductor unit 44 is shown in Figs. 17-20. The embodiment shown in Figs. 17-20 is sized for portable applications. The dimensions provided in Figs. 17-20 are given in inches. For example, as shown in Fig. 18, thermoelectric semiconductor unit may include a length LI of about 11.8 inches (30.0 cm) and a width L2 of about 5.9 inches (15.0 cm). Other dimensions shown in Fig. 19 and Fig. 20 include L3 (12.0 cm), L4 (9.9 cm), L5 (3.0 cm), L6 (18.0 cm), L7 (15.1 cm), L8 (0.71 cm), L9 (0.8 cm), and L10 (4.4 cm). Of course, other dimensions may be used in other embodiments such as for different applications. As shown in Fig. 4, for example, thermoelectric semiconductor unit 44 may be mounted on the opposite side of the temperature exchange tray 42 from the side on which the resistive heating element 46 is mounted. Thermoelectric semiconductor unit 44 may use multiple thermoelectric semiconductors (e.g., an array of n- type and p-type semiconductors), to create both a hot surface and a cold surface using the Peltier effect. Such a semiconductor array may be tightly sandwiched between a first plate and a second plate. In some embodiments, the first and second plates may be made from aluminum, copper, or heat conductive metals. For example, the first plate may be used to dissipate excess heat. In some embodiments, a fan 50 may be mounted adjacent to the first plate to assist in heat dissipation. The second plate may be mounted against the temperature-exchange tray 42. The second plate may remove heat from the heat-exchange material when the module 44 is used with the second plate being the cold side. Alternatively, the second plate may be used toheat or augment heating in those embodiments wherein the thermoelectric semiconductor unit44 is configured (e.g., with appropriate wiring for providing different voltages to the first and second sides) to act in a heating / cooling capacity. In some embodiments, the operating temperature can range from about -10° C to about 46° C.

[0065] Figs. 11-13 show an exemplary embodiment of the temperature-exchange tray 42. The embodiment shown in Figs. 11-13 is sized for portable applications with dimensions provided therein given in inches. Dimensions shown therein include Lil (7.0 inches or 17.8 cm), L12 (15.2 cm), L13 (1.9 cm), L14 (1.3 cm), L15 (0.6 cm), L16 (1.3 cm), and L17 (1.9 cm). Of course, other dimensions may be used in other embodiments such as for different applications. Figs. 14-16 show an exemplary embodiment of the conduit 48. In the embodiment shown in Figs. 14-16, the conduit 48 is sized for use with the temperatureexchange tray 42 shown in Figs. 11-13. As shown in Figs. 11-13, in some embodiments, the temperature-exchange tray 42 includes a plurality of grooves 70. The grooves 70 are configured to receive the conduit 48 therein. The conduit 48 and grooves 70 may be sized so that the conduit may securely fit within the grooves. Latches or clips may, for example, be used to secure the conduit 48 in place within the grooves 70. In some embodiments, the temperature-exchange tray may include a body that is made of a metal with suitable thermal conductivity so that heat may readily be conducted therethrough (e.g., from either of heating element 46 or thermoelectric semiconductor unit 44 to the conduit 48). For example, in some embodiments, the temperature-exchange tray may be comprised of aluminum, aluminum alloys, copper, copper alloys, or another suitable material. The temperature exchange tray 42 may be attached to drawer sliders 47 (shown in Fig. 7, for example) for easy removal of conduit “piping” 48. Alternatively, the temperature exchange tray 42 may be attached using a latching mechanism. The temperature exchange tray may have dimensions suitable for portable applications (e.g., 7 inches x 6 inches x 0.75 inches or 17.8 cm x 15.2 cm x 1.9 cm).

[0066] In some embodiments, conduit 48 may be shaped to optimize a surface area for heat exchange and may include one or more bends so that the conduit 48 may generally meander through a given surface area. For example, the conduit 48 may have at least one 180- degree bend (and up to 24) to optimize a surface area for heat exchange. For example, in the illustrated embodiment, the cooling module 40 is shown as having 5 turns in the form of 180- degree bends. However, some embodiments may have more or less turns or be shaped differently as may be suitable for use with conduits or modules of different sizes or incorporating different materials, for example. In some embodiments, conduit 48 may be comprised of disposable aluminum tubing having about 1.27 cm outer diameter and about 0.95 cm inner diameter and a length of about 130 cm. In some embodiments, conduit 48 may be disposable and made of a metal with suitably high thermal conductivity, including, for example, aluminum, aluminum alloys, copper, and copper alloys. In some embodiments, conduit 48 may be disposable and be made of or include plastic. Other embodiments include a length of tubing that encompasses the surface area of the entire temperature exchange tray.

[0067] In some embodiments, the temperature-exchange tray 42 may directly interface with the conduit 48. In some embodiments, an optional film, coating, or lining 71 may be disposed on the temperature-exchange tray 42 (e.g., along one or more of the grooves 70). The lining 71 may, for example, be configured to help improve thermal contact between the conduit 48 and tray 42 so as to help establish a robust heat exchange relationship therebetween.

[0068] In some embodiments, one or more of the grooves 70, lining 71, or the conduits 48 may at least slightly deform when the conduit is mounted to the temperatureexchange tray. For example, when the conduit 48 is aligned and pressed together with the grooves 70, either or both of the grooves 70, the lining 71, or the conduit 48 may, at least slightly, deform until the conduit 48 is fully received within the groove. In some embodiments, the shape and / or material construction of the conduit 48 and exchange tray 42 may beconfigured to help ensure that the conduit 48 may be mounted to the tray 42 so as to provide a consistent and robust heat exchange relationship therebetween.

[0069] An exemplary embodiment of a pump 132 is shown in Figs. 8 and 9. The pump 132 may, for example, be used in any of the control systems 12, 120, 220 shown in Figs. 1-3. For example, the pump 32 (as shown in any of Figs. 1-3) may be replaced with the pump 132 as shown in Figs. 8 and 9. In some embodiments, the pump 132 may include a pump head 62 including a disposable housing 68. The disposable pump housing 68 may be shaped to receive a pump shaft of the pump 132. The disposable pump housing 68 may further include an impeller 64 that may be operably engaged with the shaft through the housing so that heat exchange fluid may be pumped therethrough without directly contacting the pump shaft 70 or motor 72. Thus, a sealed pathway of fluid communication may extend through a disposable pump head 62 coupled to a non-disposable part of a pump.

[0070] A pump 32, 132 may be configured to circulate water or another heat-exchange material through a control system 12, 120, 220 in a closed system. The pump may, for example, be a variable or single-speed centrifugal pump, and may be made from plastic and / or metal. In some embodiments, the pump 32 may be variable or single-speed pump that is disposable; the pump may be centrifugal or peristaltic, and / or diaphragmatic. In some embodiments, as shown in Figs. 8 and 9, the motor 70 and shaft 72 may stay within the system, while the pump head may be removable and disposable. In some embodiments, a pump may nominally operate up to 15 L / minute at a maximum of 120 psi. In some embodiments, an operating temperature of a pump 32, 132 may range from about 0° C to about 60° C. In some embodiments, any type of pump may be used that suitably drives differential pressure from the inlet and outlet of the pump. For example, in some embodiments a pump may include either a single or double diaphragm pump, or a sump pump. As an alternative to a disposable pump, an entire pump may be used and replaced.

[0071] In some embodiments, a pump 32, 132 may comprise a disposable pump head.The pump head may consist of a housing for the water and the impeller. The pump head may latch to the shaft to transfer rotational energy. In some embodiments, the pump will nominally operate up to about 15 L / minute at a maximum pressure of about 120 psi. In some embodiments, an operating temperature may range from about 0° C to 140° C. In some embodiments, the impeller may be made of metal or other suitably rigid material.

[0072] In some embodiments, control systems described herein may be configured to maintain the temperature of circulating blood throughout an ECMO circuit as dictated by clinical requirements. The set temperature may be reached rapidly or more gradually (e.g., within about 3 minutes to about 2 hours), and may be maintained continuously for an extended time period, such as up to about one year.

[0073] In some embodiments, a control system including a heating and cooling module may comprise a distinct product configured for use with an extracorporeal membrane oxygenation or related fluid handling system. For example, a control system 12 (shown in Fig. 1) may include its own housing (e.g., an insulated housing or casing) with ports 18, 20 configured for removable and reversible coupling to related ports of an ECMO or related circuit. When the ports 18, 20 are coupled to the target device 22, heat-exchange fluid may be circulated through a heat exchanger (HE) such as may exist separately or integrated together with an oxygen and / or gas exchange membrane. Alternatively, a control system may include a conduit system that integrates a heat exchanger therein. So that, for example, the control system may be coupled to a target device in such a way as to position the heat exchanger in a heat exchange relationship with blood or another target fluid. For example, in some embodiments, the control system 120 shown in Fig. 2 may not include ports 18, 20. Rather, the control system 120 may be formed so that the conduit system 16 may, for example, slide into engagement with the target device 22. For example, control system 120 may include anintegrated heat exchanger (HE) designed for providing heat or removing heat from blood or another fluid. In some embodiments, an extracorporeal fluid handling system 10, 100, 200 may comprise a distinct item, such as may be packaged in an integrated casing.

[0074] In some embodiments, one or more disposable reservoirs may be used to prime a system with heat-exchange material (e.g., water) and remove air. For example, in some embodiments, a disposable reservoir may include an obstructed outflow line or valve that connects to a disposable conduit system 16, 19 as well as a unidirectional inflow with a oneway valve to allow flow back into the disposable reservoir or priming bag. A branch may flow directly back into the disposable reservoir or priming bag, allowing for de-airing of the system. Such a flow pathway may be used as a recirculation loop (e.g., composed of plastic or other suitable conduit tubing) until a desired temperature of water is reached.

[0075] For example, as shown in Fig. 21, a disposable reservoir 300 may include an obstructed outflow line 302 that directly attaches to a disposable conduit system 16. As shown therein, a valve 304 may control flow of heat-exchange material from the outflow line 302 to the disposable conduit system 16. A unidirectional inflow 308 with a one-way valve 306 allows for flow back into the disposable reservoir 300 or to a separate priming bag.

[0076] Generally, microcontroller 27 may comprise any suitable component(s). For example, microcontroller 27 may include a CPU core including an ESP32-WROOM-32U (Espressif Systems, Shanghai China). The microcontroller 27 may serve as the motherboard for the control system and may provide memory used in system operation. The microcontroller 27 may, for example, be connected to a breadboard along with any combination of sensors and electronic components as described herein. The microcontroller 27 may contain relays that allow the components of a control system 12, 120, 220, 400 to communicate and operate, and may house relay circuitry, power modules, and programming for the digital display interface.

[0077] In some embodiments, a battery pack may be used as a DC power source in some embodiments of portable control systems 10, 100, 200. The battery pack may be used to power the control system when it is not connected to AC power and may be used for transportability. In one example, a 36V lithium battery may be used. In some embodiments, there may be a failsafe mechanism such as may maintain the amperage at 10A, for example. When it is in use, the battery may be connected to the motherboard and its charger. Otherwise, the control system may be powered by AC power. In one example, the battery pack may be suitable for powering the control system for a minimum of about 30 minutes.

[0078] As shown in Fig. 1, in some embodiments, a control system 12 may include a suitable flow rate sensor 33a, 33b. For example, the flow rate sensor 33a, 33b may be a Digiten G 1 / 2-inch flow sensor. The flow rate sensor may, for example, be connected at any suitable position along a fluid circulation system 21, 23, 25. For example, as shown in Fig. 1, flow rate sensors 33a and 33b may be included in a fluid circulation system 21. Although two flow rate sensors are shown in the illustrated embodiment, other configurations of flow rate sensors may be used. For example, in some embodiments, a single flow rate sensor may be used. A flow rate sensor may, for example, be wrapped around or positioned inside of a conduit 16, 19. The flow rate sensors may determine the flow rate of heat exchange fluid as it passes through the disposable tubing. In some embodiments, the flow rate sensor may be placed inside the casing and on the outlet. It may communicate with the microprocessor to ultimately show flow rate on a display screen (not shown). In some embodiments, the flow rate may be up to about 30 L / min. In some embodiments, the flow rate sensor may send an ultrasonic pulse through the heat exchange fluid (e.g., water) to detect its flow.

[0079] In some embodiments, one or more temperature sensors may be attached to piping or sit in the removable temperature-exchange tray instead of being directly attached to the piping. For example, as shown in Fig. 13, temperature sensors 35a, 35b may be coupled tothe temperature-exchange tray 44. In some embodiments, the tray may include a shaped slot or channel formed so as to ensure that the temperature sensor is oriented correctly. The sensors themselves may, for example, be composed of plastic, silicon rubber, and / or metal, and they may be self-adhesive. In one example, the temperature sensor may be a Bojack DS18B20 temperature sensor. The signal of the temperature sensor may be sent to the microcontroller for suitable display in analog or digital form, for example. The sensors may either be attached using self-adhesive tape, or they may be wrapped around the disposable tubing, for example. The temperature range may be from about -50°C to about 200°C (or over some other suitable range), and they can be used with either curved or flat surfaces.

[0080] In some embodiment, any combination of components of control system 12, 120, 220 may be housed together in an outer casing or housing. For example, in some embodiments, any combination of the heating and cooling module 14, 40, pump 32, 132, and conduits 16, 19 may be integrated together in a common casing or housing. The outer casing or housing may be light weight and durable and may be made of a hard plastic polymer material including but not limited to polycarbonate sheets. The outer casing may have a door or opening to slide out the temperature exchange tray to pop out copper tubing for replacement. The insulation may, for example, be made of a thin insulating polyurethane foam covering each internal wall. The casing will feature two gaps in the insulation with holes drilled through the casing for air from the fan and heat sink to escape.

[0081] Figs. 25-26 shows another exemplary embodiment of a control system 400. Fig. 25 is a side view of the control system 400. In some embodiments, the control system may include a side panel (removed from Fig. 25 to show internal system components). The side panel may, for example, be removable or include a door for accessing internal system components. As shown in Fig. 25, the control system 400 may include a drawer 450 configured for holding a temperature exchange tray 442. A pair of drawer slides or rails 452 may be usedto slidably position the temperature-exchange tray 442 in engagement with a thermoelectric semiconductor unit 444. A heating element 446 may be disposed on the opposite side of the temperature-exchange tray 442. Generally, the thermoelectric semiconductor unit 444 and the heating element 446 may be configured similarly to that described above for thermoelectric semiconductor unit 44 and the heating element 46. In Fig. 25, the drawer 450 is shown in a closed position, which is also the operating position in the illustrated embodiment. Fig. 26 is a perspective view of the control system 400 shown with the drawer 450 in an open position. In the open position, the temperature exchange tray 442 may be readily accessed for ease of removal of disposable system components including, for example, the temperature exchange conduit 419.

[0082] Temperature exchange conduit 419 is shown in Fig. 25 to be in fluid communication with each of the additional conduits 416a, 416b, and 416c. The temperature exchange conduit 419 may be comprised of a material suitably configured for heat exchange with circulating heat exchange. The temperate exchange conduit 419 may, for example, be comprised of disposable aluminum tubing. In some embodiments, conduit 419 may be disposable and made of a metal with suitably high thermal conductivity, including, for example, aluminum, aluminum alloys, copper, and copper alloys. In some embodiments, conduit 48 may be disposable and be made of or include plastic. Generally, the supporting conduits 416a, 416b, and 416c may be composed of the same or different material form the temperature exchange conduit 419. In some embodiments, one or more of the conduits 416a, 416b, and 416c may be formed integrally with the temperature exchange conduit 419. For example, in some embodiments, each of the conduits 419, 416a and 416c may be integrated together as a single conduit.

[0083] Additional elements shown in Fig. 25 and Fig. 26 include a system housing 402, an electronics storage cub 404, a fastening mount 413, a heating and cooling module 414, afirst connector 418, a second connector 420, a display screen 423, a mounting bracket 424, a pump body 432, a flow sensor assembly 449, a drawer slider 450, and a pump head 462. Electronics storage cub 404 may, for example, provide a secure housing for electronics components of the system. For example, any combination of electronic components, including for example, microcontroller 27 and battery 29 may be housed within electronics storage cub 404.

[0084] The control system 400 is configured so that disposable components of the system 400 may be easily replaced. For example, in some embodiments, the control system 400 may be configured to allow the entirety of the fluid circulation system 421 (shown in Fig. 27 and including all system components that come into direct contact with heat exchange fluid) to be removed together as an integrated component assembly thereby simplifying replacement of disposable system components. For example, as shown in Fig. 27, the fluid circulation system 421 may be integrated in the form of component assembly 460 comprised of various conduits (e.g., the conduits 416a, 416b, 416c, 419), and the pump head 462. Fluid connectors 418, 420 may or may not come into contact with heat exchange material. And, in some embodiments, fluid connectors 418, 420 may be disposed of together with other components shown in Fig. 27 (e.g., in the form of disposable component assembly 460). In other embodiments, fluid connectors 418, 420 may be connected to the various conduits 416a, 416b, 416c in a way so that the connectors 418, 420 do not come into direct contact with circulating heat exchange fluid. In some of those embodiments, the connectors 418, 420 may be reused and only disposed of should they become damaged, for example. In some embodiments, a control system 400 may be provided with a kit including common connectors used in the medical industry. These connectors may include, for example, any combination of quickconnectors, barbed connectors, bayonet connectors and or other suitable connectors.

[0085] As shown in Fig. 26 and in Fig. 34, a pump may include a removable pump head 462 and a pump body 432. Notably, as shown in Fig. 27, in some embodiments, the pump head 462 may be removed as part of the component assembly 460. In some embodiments, the pump head 462 may be removably connected to the pump body 432 via a threaded connection. For some threaded connections, turning the pump head 462 without disconnecting the conduits 416a, 416b coupled thereto may cause the conduits 416a, 416b to twist complicating or preventing removal of the pump head 462. Accordingly, in some embodiments, the conduits 416a, 416b may be configured so that they may be easily disconnected from the pump head 462 prior to removal of the pump head 462. The conduits 416a, 416b may, for example, be connected to the pump head 462 via one or more removable connectors such as may include a knurled nut connector, for example. Fig. 34 shows an exemplary embodiment of a pump including a removable pump head 462 and a pump body 432.

[0086] In some embodiments, the pump head 462 may be connected to the pump body 432 using connectors that do not require the conduits 416a, 416b to be disconnected from the pump head 462 before the pump head 462 is removed from the pump body 432. For example, in some embodiments, the pump head 462 may be connected to the pump body 432 using an interference fit or snap fit connection. The pump head 462 may, for example, include a deformable end that may be deformed in shape when inserted over a flange or rim bordering the pump body 432. Thus, the pump head 462 may be disconnected from the pump body 432 without rotating the pump head 462.

[0087] Fig. 28 shows still another alternative embodiment for coupling between a pump head 462 and a pump body 432. As shown therein, the pump head 462 may include each of a first body 500 and a second body 502. The first body 502 and the second body 504 may, for example, comprise cylindrical bodies that may be rotatably connected to each other at rotatable connection 503. The rotatable connection 503 may for example be configured to rotate usingbearings. The second body 502 may be threadably connected to the pump body 432. The second body 502 may be rotated independently from first body 500. Thus, it may be threadably connected or disconnected from the pump body 432 without twisting the conduits 416a, 416b connected thereto. Accordingly, the pump head 462 may be removed without first disconnecting the conduits 416a, 416b from the pump head 462.

[0088] The system 400 may be configured so that disposable systems components are mounted therein for ease of removal. For example, as shown in Fig. 25 and Fig. 26, the control system 400 may include a fastening mount 413. Fastening mount 413 may be configured to help secure the component assembly 460 in place during operation. Fastening mount 413 may, for example, include a collar 433 and latch 434. The latch 434 may, for example, include a hinge so that it may be moved between a first position secured around conduit 416a and a second position wherein the conduit 416a is removed from engagement with the collar 433.

[0089] In some embodiments, disposable system components may further be secured within the system at one or more other positions. For example, to remove the disposable component assembly 460 from the control system 400, a user may adjust the fastener 413 so as to fee the conduit 416a from the collar 433 (as shown in Fig. 25). A user may further disconnect the conduits 416b and 416c from secured positions mounted to the right-side wall of housing 402. For example, in the illustrated embodiment, each of the connectors 418 and 420 are engaged with the right-side wall of the housing 402 via connectors 470 which may be configured to engage the right-side wall of the housing 402 at grooves or indents 454, 456. To disconnect the connectors 418, 420, a user may, for example, simply rotate a collar 471 so as to translate the collar 471 along a supporting base 473 (see Fig. 25) thereby disengaging the collar 471 from the housing 402. In a tightened position a portion of the housing 402 around the indents 454, 456 may be sandwiched between the collar 471 and a flange or rim 477.

[0090] With the conduits 416a, 416b, 416c released from their respective connections, a user may then disengage the pump head 462 from the pump body 432. For example, in some embodiments, disconnecting the pump head 462 from the pump body 432 may be done without having to disconnect the conduits 416a, 416b, 416c from the pump head 462. In some embodiments, the conduits 416a, 416b may be disconnected from the pump head 462 so that a threadably engaged pump head may be disengaged from the pump body 432 without twisting the respective conduits 416a, 416b. Notably, in some embodiments, the pump head 462 may be disengaged from the pump body 432 by moving the pump head 462 along an axis Al (shown in Fig. 26). Likewise, drawer 450 (mounted on a pair of drawer slides 452, an individual drawer slide 452 shown in Fig. 29) may be translated along the axis A2 (see Fig. 26). The axes Al and A2 may be oriented parallel to each other. Accordingly, the various conduits 461a, 461b, 461c and 419 may be supported and translated as necessary when a user moves the pump head 462 along the axis A2 when disengaging the pump head 462 from the pump body 432. For example, those various components may move together as an integrated component assembly. Likewise, in some embodiments, an integrated component assembly 460 may be installed as an integrated component. As shown in Fig. 26, the drawer slides 452 may provide sufficient travel for the drawer 450 so that the pump head 462 may be fully disengaged form the pump body 432 and so that the conduits 419 may be easily removed from the tray 442.

[0091] An exemplary embodiment of the temperature exchange tray 442 is shown in Fig. 30. The embodiment shown in Fig. 30 is sized for portable applications with dimensions provided therein given in inches. Dimensions shown therein include L30 (7.1 inches or 18.0 cm), L31 (13.0 cm), and L32 (2.4 cm). Of course, other dimensions may be used in other embodiments such as for different applications. An exemplary embodiment of conduit 419 is shown in Fig. 31. The conduit 419 is sized for use with the temperature-exchange tray 442 shown in Fig. 30. As shown in Figs. 30-31, in some embodiments, the temperature-exchangetray 442 includes a plurality of grooves 570. The grooves 570 are configured to receive the conduit 419 therein. The conduit 419 and grooves 570 may be sized so that the conduit may securely fit within the grooves. In some embodiments, latches or clips may, for example, be used to secure the conduit 419 in place within the grooves 570. In some embodiments, the temperature-exchange tray may include a body that is made of a metal with suitable thermal conductivity so that heat may readily be conducted therethrough (e.g., from either of heating element 446 or thermoelectric semiconductor unit 444 to the conduit 419). For example, in some embodiments, the temperature-exchange tray may be comprised of aluminum, aluminum alloys, copper, copper alloys, or another suitable material.

[0092] Although the foregoing specific details describe certain embodiments of this disclosure, persons of ordinary skill in the art will recognize that various changes may be made in the details of the disclosed subject matter without departing from the spirit and scope of the invention as defined in the appended claims and other claims that may be drawn to this invention and considering the doctrine of equivalents. Among other things, any feature described for one embodiment may be used in any other embodiment, and any feature described herein may be used independently or in combination with other features. Also, unless the context indicates otherwise, it should be understood that when a component is described herein as being mounted or connected to another component, such mounting or connection may be direct with no intermediate components or indirect with one or more intermediate components. Therefore, it should be understood that this invention is not to be limited to the specific details shown and described herein.

Claims

We claim:

1. A heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray configured for positioning in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element when the temperatureexchange tray is mounted in the heating and cooling module; and a disposable conduit configured for mounting within said temperature-exchange tray.

2. The heating and cooling module of claim 1 wherein the thermoelectric semiconductor unit comprises a semiconductor array disposed between a first plate and a second plate and further comprising; a voltage source configured for applying a voltage across the semiconductor array so as to cool a working fluid circulated through said disposable conduit; a polarity of the voltage source being configured for adjustment so as to provide for alternative heating or cooling of the working fluid.

3. The heating and cooling module of claim 1 the temperature-exchange tray being slidably mounted in the heating and cooling module so as to provide access for removing the disposable conduit.

4. The heating and cooling module of claim 1 the temperature-exchange tray being mounted to the thermoelectric semiconductor unit using one or more rails.

5. The heating and cooling module of claim 1 wherein the temperature-exchange tray is slidably mounted to the thermoelectric semiconductor unit.

6. The heating and cooling module of claim 1 further including: a pump including a disposable pump head mounted to a non-disposable pump body.

7. The heating and cooling module of claim 1 wherein the heating and cooling module is configured for portable applications.

8. A heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray being in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element; and a disposable conduit configured for mounting within said temperature-exchange tray; wherein the thermoelectric semiconductor unit comprises a semiconductor array configured for alternative heating or cooling of the temperature-exchange tray.

9. A heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray being in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element; and a disposable conduit configured for mounting within said temperature-exchange tray.

10. The heating and cooling module of claim 9, wherein the temperature-exchange tray is slidably mounted in the heating and cooling module so as to provide access for removing the disposable conduit.

11. The heating and cooling module of claim 10 wherein the temperature-exchange tray is mounted to the thermoelectric semiconductor unit using one or more rails.

12. An extracorporeal membrane oxygenation apparatus comprising: a heating and cooling module configured for temperature regulation of a working fluid circulated therein, the heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray being in aheat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element; and a disposable conduit configured for mounting within a temperatureexchange tray.

13. The extracorporeal membrane oxygenation apparatus of claim 12 wherein the temperature-exchange tray is slidably mounted in the heating and cooling module so as to provide access for removing the disposable conduit.

14. The extracorporeal membrane oxygenation apparatus of claim 12 wherein the temperature-exchange tray is mounted to the thermoelectric semiconductor unit using one or more rails.

15. The extracorporeal membrane oxygenation apparatus of claim 12 wherein the temperature-exchange tray is slidably mounted to the thermoelectric semiconductor unit.

16. The extracorporeal membrane oxygenation apparatus of claim 12 further including: a pump including a disposable pump head mounted to a non-disposable pump body.

17. The extracorporeal membrane oxygenation apparatus of claim 12, wherein the apparatus is portable.

18. An extracorporeal fluid handling apparatus comprising: a control system comprising: a heating and cooling module including a temperature-exchange tray and a disposable conduit configured for mounting within said temperatureexchange tray, the heating and cooling module further including a thermoelectric semiconductor unit and at least one heating element; and a pump configured for applying fluid pressure for circulating a working fluidthrough said disposable conduit, the pump including a disposable pump head mounted to a non-disposable pump body; and a target device coupled to said control system, the target device including one or more conduits for routing said working fluid along a fluid pathway so as to position the working fluid in a heat exchange relationship with a fluid circulating therethrough.

19. The extracorporeal fluid handling apparatus of claim 18 wherein said target device comprises a blood oxygenator, a heart lung machine, or a blood purifier.

20. A temperature control system configured for controlling the temperature of a working fluid circulated through a heating and cooling module, the control system comprising: a temperature-exchange tray, the temperature exchange tray configured for positioning in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element when the temperatureexchange tray is mounted in the heating and cooling module; and a first disposable conduit configured for mounting within said temperatureexchange tray; the temperature-exchange tray being slidably mounted in the heating and cooling module so as to provide access for removing the first disposable conduit.

21. The temperature control system of claim 20 wherein the first disposable conduit is part of a fluid circulation system comprising all system components that come into contact with said working fluid when the working fluid is circulated through the control system.

22. The temperature control system of claim 21 further comprising a pump including a disposable pump head mounted to a non-disposable pump body, the disposable pump head forming a part of said fluid circulation system.

23. The temperature control system of claim 22 wherein the fluid circulation system is configured for removal as an integrated and disposable component assembly.

24. The temperature control system of claim 21 wherein the fluid circulation system is configured for removal as an integrated and disposable component assembly.

25. The temperature control system of claim 20 further comprising a pump including a disposable pump head mounted to a non-disposable pump body.

26. The temperature control system of claim 25 wherein said disposable pump head is threadably mounted to said non-disposable pump body.

27. The temperature control system of claim 25 wherein said disposable pump head is mounted to said non-disposable pump body through an interference fit.

28. The temperature control system of claim 27 wherein the disposable pump head and pump body are aligned along an axis that is substantially parallel to an axis about which the temperature exchange try is slidably mounted.

29. The temperature control system of claim 28 wherein the disposable pump head may be disconnected from the pump body without having to disconnect one or more fluid conduits connected thereto.

30. The control system of claim 20 wherein the temperature-exchange tray is mounted using one or more rails.

31. A method of removing disposable components from a temperature control system configured for controlling the temperature of a working fluid circulated through a heating and cooling module, the method comprising: releasing one or more securing mounts from a fluid circulation system; and removing the fluid circulation system as a one piece integrated and disposable component assembly.

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