Modular heater cooler with disposable heat transfer fluid circuit

Abstract

A modular heater cooler with a disposable heat transfer fluid circuit is disclosed. Further disclosed is a system (20) comprising: a heater / cooler module (22) for heating / cooling a first fluid in a main circuit (28); a heat transfer fluid circuit (24) for providing a second fluid to a target device (38) to heat / cool the target device (38); and a heat exchanger (26) comprising at least part of the primary circuit (28) and at least part of a secondary circuit (36) through which the second fluid flows to facilitate heat transfer between the first fluid and the second fluid. The primary circuit (28) and the secondary circuit (36) are separate circuits, and the first fluid and the second fluid remain separate in the system. Moreover, the system is modular such that the elements may be stacked to increase heating / cooling capability and / or increase the number of heating / cooling channels, and the system is compatible with portable applications, such as ambulance, aircraft, and helicopter applications, and with battery operation and / or use of uninterruptible power supplies.

Description

[0001] This application is a divisional application of the patent application with the application number "201780097297.X", the application date "October 6, 2017", and the title "Modular Heater Cooler with a Disposable Heat Transfer Fluid Circuit". Technical Field

[0002] The present disclosure relates to a system for heating and / or cooling (heating / cooling) a target device. More specifically, the present disclosure relates to a system for heating / cooling a patient or an organ or other fluid (such as blood) directly or through a secondary fluid circuit (e.g., a heat exchanger) in an oxygenator of a cardiopulmonary machine during extracorporeal blood circulation. Background Art

[0003] An oxygenator is a device for extracorporeal blood oxygenation. Generally, an oxygenator is used in a cardiopulmonary machine or an extracorporeal membrane oxygenation (ECMO) device, which includes a membrane oxygenator that can largely avoid embolism. With the help of a gas mixer and a flowmeter, the transfer of oxygen and carbon dioxide is reliably controlled.

[0004] In an oxygenator, the patient's blood is heated or cooled and oxygenated. The oxygenator includes a heat exchanger for heating or cooling the blood. In the oxygenator, a heat exchange medium flows through the heat exchanger and transfers heat to the blood to heat the blood, or absorbs heat from the blood to cool the blood. Generally, the heat exchange medium is supplied to the heat exchanger by a pump unit, and after heat exchange with the blood, the heat exchange medium is discharged from the heat exchanger by the same pump unit or another pump unit. A heat exchange medium such as water is heated or cooled in a heater / cooler before being directed to the heat exchanger. Due to its size and complex structure, the heater / cooler is separate from the cardiopulmonary machine or ECMO.

[0005] In some cases, if not properly cleaned or maintained, the heat exchange medium of the heater / cooler may have contamination problems. In this case, there is a risk that the equipment and / or air in the operating room (OR) may be contaminated and bacteria will enter the patient's blood from the contaminated heat exchange medium. Moreover, for most applications, the heater / cooler may be over-powered, and there are power consumption and power compatibility problems. In addition, due to the large size of the heater / cooler, its usability may be limited and it may not be transportable. Moreover, due to the size-to-power ratio of the heater / cooler, it may not be suitable for intensive care unit (ICU) applications. Summary of the Invention

[0006] The present invention relates to heater / cooler configurations which advantageously eliminate the need for a fluid reservoir (which is typically open to the atmosphere) to contain a heat exchange medium. Additionally, these configurations provide two different fluid circuits, a first circuit being heated by a heater / cooler device and a secondary circuit being in communication with a target device (e.g., a heat exchanger). Thus, in the event that the heat exchange medium should become contaminated, any such contamination cannot be transmitted to the target device and thus cannot contaminate the patient's blood.

[0007] As described in the examples, Example 1 is a system comprising: a heater / cooler module including a main circuit and configured to heat / cool a first fluid in the main circuit; a heat transfer fluid circuit configured to supply a second fluid to a target device to heat / cool the target device; and a heat exchanger including at least a portion of the main circuit through which the first fluid flows and at least a portion of a secondary circuit through which the second fluid flows to facilitate heat transfer between the first fluid and the second fluid. The main circuit and the secondary circuit are separate circuits such that the first fluid and the second fluid remain separate in the system.

[0008] Example 2 is the system of Example 1, wherein the main circuit is a permanent part of the heater / cooler module.

[0009] Example 3 is the system of Example 1, wherein the main circuit is a hermetically sealed closed circuit containing the first fluid.

[0010] Example 4 is the system of Example 1, wherein at least a portion of the secondary circuit is part of the heater / cooler module and is non-disposable such that at least a portion of the secondary circuit is cleaned and disinfected after one or more uses.

[0011] Example 5 is the system of Example 1, wherein the secondary circuit is part of the heat transfer fluid circuit.

[0012] Example 6 is the system of Example 1, wherein the secondary circuit is part of the heat transfer fluid circuit and is disposable.

[0013] Example 7 is the system of Example 1, wherein the heat transfer fluid circuit is a disposable circuit for single use.

[0014] Example 8 is the system of Example 1, wherein the heat transfer fluid circuit is a reusable circuit that is cleaned and disinfected after one or more uses.

[0015] Example 9 is the system of Example 1, which includes at least one of two or more heat exchangers, two or more heater / cooler modules, and two or more heat transfer fluid circuits.

[0016] Example 10 is the system of Example 1, wherein the secondary circuit is a hermetically sealed closed circuit containing the second fluid.

[0017] Example 11 is the system of Example 1, where the heater / cooler module includes a heat pump to heat / cool the first fluid in the main circuit.

[0018] Example 12 is the system of Example 1, where the heater / cooler module includes an auxiliary heat exchanger configured to receive a third fluid, and the auxiliary heat exchanger facilitates heat transfer between the third fluid and the first fluid in the main circuit.

[0019] Example 13 is the system of Example 1, where the heat exchanger includes a thermoelectric heater / cooler thermally coupled to the heat exchanger to heat / cool at least one of the first fluid and the second fluid.

[0020] Example 14 is the system of Example 1, where the heat exchanger includes an auxiliary electric heater configured to heat the second fluid in the heat exchanger.

[0021] Example 15 is the system of Example 1, where the target device includes an oxygenator heat exchanger.

[0022] Example 16 is the system of Example 15, which includes a first temperature sensor configured to measure the temperature of the blood and a second temperature sensor configured to measure the temperature of at least one of the first fluid and the second fluid, where the system is configured to maintain a predetermined temperature offset between the blood and at least one of the first fluid and the second fluid.

[0023] Example 17 is the system of Example 1, where the heat exchanger includes one or more auxiliary electric heaters used to dry and thermally disinfect the heat exchanger during thermal disinfection.

[0024] Example 18 is the system of Example 1, where the heat exchanger includes one or more temperature sensors configured to measure the temperature of the heat exchanger in the absence of the second fluid.

[0025] Example 19 is the system of Example 1, where the heat exchanger includes a first module configured to receive the first fluid and a disposable module configured to receive the second fluid.

[0026] Example 20 is the system of Example 19, where the first module includes one or more auxiliary electric heaters to heat at least one of the first fluid and the second fluid.

[0027] Example 21 is the system of Example 19, where the first module includes a temperature sensor configured to measure the temperature of at least one of the first fluid and the second fluid.

[0028] Example 22 is the system of Example 19, wherein the disposable module includes one or more auxiliary electric heaters to heat at least one of the first fluid and the second fluid.

[0029] Example 23 is the system of Example 19, wherein the disposable module includes at least one temperature sensor configured to measure the temperature of at least one of the first fluid and the second fluid.

[0030] Example 24 is the system of Example 19, wherein the first module includes a first plate heat exchanger and the disposable module includes a second plate heat exchanger.

[0031] Example 25 is the system of Example 1, wherein the heat exchanger includes a plate heat exchanger configured to receive the first fluid and a disposable plate heat exchanger configured to receive the second fluid.

[0032] Example 26 is a system that includes: a heater / cooler module that includes a main circuit and a heat pump for heating / cooling a first fluid in the main circuit; a heat transfer fluid circuit that includes a secondary circuit containing a second fluid and configured to supply the second fluid to a target device in the secondary circuit to facilitate heat transfer between the second fluid and a target fluid in the target device; and a heat exchanger circuit that includes at least a portion of the main circuit through which the first fluid flows and at least a portion of the secondary circuit through which the second fluid flows to regulate the temperature of the second fluid via the first fluid.

[0033] Example 27 is the system of Example 26, wherein the main circuit includes heat exchanger coils in a heat exchanger and the secondary circuit includes a container sealed around the heat exchanger coils.

[0034] Example 28 is the system of Example 27, wherein the first fluid flows through the heat exchanger coils to facilitate heat transfer between the first fluid and the heat exchanger coils, thereby achieving a first temperature of the heat exchanger coils, and the second fluid flows around the heat exchanger coils to facilitate heat transfer between the second fluid and the heat exchanger coils, thereby achieving a second temperature of the second fluid.

[0035] Example 29 is the system of Example 27, wherein the heat exchanger includes an auxiliary electric heater configured to supply heat to the second fluid.

[0036] Example 30 is the system of Example 27, wherein the heat exchanger includes at least one temperature sensor configured to provide a temperature measurement of the second fluid.

[0037] Example 31 is the system of Example 26, wherein the heat exchanger includes a heat exchanger structure and the secondary circuit includes a container sealed around the heat exchanger structure.

[0038] Example 32 is the system of Example 31, wherein the first fluid and the heat exchanger structure facilitate heat transfer between the first fluid and the heat exchanger structure to reach the first temperature of the heat exchanger structure, and the second fluid flows through the container and around the heat exchanger structure in the container to facilitate heat transfer between the heat exchanger structure and the second fluid to reach the second temperature of the second fluid.

[0039] Example 33 is the system of Example 31, wherein the heat exchanger includes an auxiliary electric heater configured to supply heat to the second fluid.

[0040] Example 34 is the system of Example 31, wherein the heat exchanger includes a temperature sensor configured to provide a temperature measurement of the second fluid.

[0041] Example 35 is the system of Example 26, wherein the heater / cooler module includes an auxiliary heat exchanger configured to receive a third fluid to facilitate heat transfer between the third fluid and the first fluid in the main circuit.

[0042] Example 36 is the system of Example 26, wherein the heat exchanger includes a thermoelectric heater / cooler coupled to the heat exchanger to heat / cool the first fluid in the main circuit.

[0043] Example 37 is the system of Example 26, wherein the heat transfer fluid circuit is a single-use disposable unit.

[0044] Embodiment 38 is a method of heating / cooling a target fluid in a target device via a heater / cooler module, the heater / cooler module including a first fluid in a main circuit, a pump, a heater / cooler element, and a heat exchanger, the method comprising: pumping the first fluid through the main circuit and the heat exchanger via the pump; heating / cooling the first fluid in the main circuit with the heater / cooler element; providing a second fluid in a secondary circuit separate from the main circuit such that the first fluid and the second fluid are maintained as separate fluids; pumping the second fluid through the secondary circuit and the heat exchanger; facilitating heat transfer in the heat exchanger between the second fluid in the secondary circuit and the first fluid in the main circuit; and providing the second fluid to the target device to facilitate heat transfer between the second fluid and the target fluid.

[0045] Example 39 is the method of Example 38, wherein heating / cooling the first fluid comprises heating / cooling the first fluid in the main circuit with a heat pump.

[0046] Example 40 is the method of Example 38, wherein heating / cooling the first fluid comprises heating / cooling the first fluid in the main circuit with an auxiliary heat exchanger in the heater / cooler module, the auxiliary heat exchanger being configured to receive a third fluid to facilitate heat transfer between the third fluid and the first fluid in the main circuit.

[0047] Example 41 is the method of Example 38, wherein heating / cooling the first fluid comprises heating / cooling the first fluid in the main circuit with a thermoelectric heater / cooler coupled to a heat exchanger.

[0048] Example 42 is the method of Example 38, which includes heating at least one of the first fluid and the second fluid in the heat exchanger with one or more auxiliary electric heaters coupled to the heat exchanger.

[0049] Example 43 is the method of Example 38, wherein promoting heat transfer between the second fluid in the secondary circuit and the first fluid in the main circuit comprises pumping the first fluid through a heat exchanger coil that is part of the main circuit and located in the heat exchanger, and pumping the second fluid through a container sealed around the heat exchanger coil such that the second fluid flows around the heat exchanger coil.

[0050] Example 44 is the method of Example 38, wherein promoting heat transfer between the second fluid in the secondary circuit and the first fluid in the main circuit comprises pumping the first fluid through a heat exchanger structure that is part of the main circuit and located in the heat exchanger, and pumping the second fluid through a container sealed around the heat exchanger structure such that the second fluid flows around the heat exchanger structure.

[0051] Example 45 is the method of Example 38, wherein promoting heat transfer between the second fluid in the secondary circuit and the first fluid in the main circuit comprises pumping the first fluid through a first plate heat exchanger that is part of the main circuit and located in the heat exchanger, pumping the second fluid through a second plate heat exchanger that is part of the secondary circuit and the heat transfer fluid circuit, and promoting heat transfer between the first plate heat exchanger and the second plate heat exchanger to heat / cool the second fluid.

[0052] Example 46 is the method of Example 38, which includes adjusting the temperature of a target fluid in a target device by measuring the fluid temperature of at least one of the first fluid and the second fluid.

[0053] Example 47 is the method of Example 38, which includes maintaining a predetermined temperature offset between the target fluid in the target device and at least one of the first fluid and the second fluid.

[0054] Although multiple embodiments are disclosed, other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the present disclosure. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Figure 1A diagram illustrating a modular heating / cooling system according to an embodiment of the present disclosure.

[0056] Figure 2 A diagram illustrating a stacked modular heating / cooling system including a first modular heating / cooling system and a second modular heating / cooling system according to an embodiment of the present disclosure.

[0057] Figure 3A A diagram illustrating a heater / cooler module and a heat exchanger according to an embodiment of the present disclosure.

[0058] Figure 3B A diagram illustrating a heat transfer fluid circuit and a heat exchanger according to an embodiment of the present disclosure.

[0059] Figure 4A A diagram illustrating a heat exchanger according to an embodiment of the present disclosure.

[0060] Figure 4B A diagram illustrating a second module removed from a first module according to an embodiment of the present disclosure.

[0061] Figure 5 A diagram illustrating another heat exchanger according to an embodiment of the present disclosure.

[0062] Figure 6 A diagram illustrating another heat exchanger according to an embodiment of the present disclosure.

[0063] Figure 7 A flowchart illustrating a method of heating / cooling a target fluid in a target device via a heater / cooler module according to an embodiment of the present disclosure.

[0064] Although the present disclosure may be subject to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. However, the intention is not to limit the present disclosure to the particular embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternative forms falling within the scope of the present disclosure as defined by the appended claims. Detailed Description

[0065] Figure 1FIG. for illustrating a modular heating / cooling system 20 according to an embodiment of the present disclosure. The modular heating / cooling system 20 includes a heater / cooler module 22, a heat transfer fluid circuit 24, and a heat exchanger 26. Different parts of the system 20 (including the heater / cooler module 22, the heat transfer fluid circuit 24, and / or the heat exchanger 26) can be "stacked" or coupled to other similar parts to provide an increase in the heating / cooling capacity of the system 20 and / or an increase in the number of heating / cooling channels. For example, multiple heater / cooler modules 22 and / or multiple heat transfer fluid circuits 24 and / or multiple heat exchangers 26 can be "stacked" to provide an increase in heating / cooling capacity and / or an increase in heating / cooling channels. Moreover, having multiple similar parts provides redundancy in the event of a failure in any one of the parts, and modularity allows the system 20 to be customized to accommodate different power consumption requirements and provide optimized heating / cooling capacity according to the needs of different applications.

[0066] In most applications, the system 20 includes each of the heater / cooler module 22, the heat transfer fluid circuit 24, and / or the heat exchanger 26. In these embodiments, the system 20 consumes 500 - 600 watts, which makes the system 20 compatible with portable applications such as ambulance, aircraft, and helicopter applications. Moreover, the low power consumption makes the system 20 compatible with battery operation and the use of uninterruptible power supplies (UPS). In addition, the low power consumption makes the system 20 compatible with electrical systems in multiple countries / regions where the system 20 can be plugged into a single power outlet without overloading the single power outlet. Thus, the system 20 can be used in Europe where a single power outlet can supply up to 3.5 kW, in the United States where a single power outlet can supply 1.8 kW, and in Japan where a single power outlet can supply only up to 1.5 kW.

[0067] Moreover, the modular heating / cooling system 20 has a size advantage, making it compatible with applications in small areas, such as placing the system 20 or components of the system 20 near a heart-lung machine (HLM). In some embodiments, the system 20 occupies only an area or volume of 0.5×0.5×0.5 meters. This, together with the low power consumption, makes the system 20 suitable for portable applications.

[0068] The system 20 can be used in different heating / cooling applications in the medical field. These medical field applications include heating / cooling of blood in an oxygenator, heating or cooling of one or more drugs in cardioplegia solution, heating / cooling of clothing or other items (such as blankets, high and low temperature procedures), and heating / cooling of fluids in organ perfusion. Additionally, the modular heating / cooling system 20 can be used in cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO), such as in an intensive care unit (ICU).

[0069] The heater / cooler module 22 includes a main circuit 28, and the main circuit 28 includes a heater / cooler element 30 fluidly coupled to a main circuit pump 32 via a main circuit pipe 34. The main circuit 28 includes a first fluid in the main circuit 28, and the main circuit pipe 34 is fluidly coupled to the heat exchanger 26. In some embodiments, the heater / cooler element 30 includes a heat pump. In some embodiments, the main circuit pump 32 includes an HLM pump and / or an independent pump. In some embodiments, the first fluid includes water. In some embodiments, the main circuit 28 is a permanent part of the heater / cooler module 22.

[0070] In some embodiments, the main circuit 28 is a closed loop containing the first fluid. In some embodiments, the main circuit 28 is an airtight sealed closed loop containing the first fluid. In embodiments where the main circuit 28 is a closed loop, the system 20 prevents contamination of the OR due to an open air tank containing the first fluid. Moreover, these embodiments eliminate the need to disinfect the main circuit 28.

[0071] The heat transfer fluid circuit 24 includes a secondary circuit 36, and the secondary circuit 36 includes a target device 38 fluidly coupled to a secondary circuit pump 40 via a secondary circuit pipe 42. The secondary circuit 36 includes a second fluid in the secondary circuit 36, and the secondary circuit pipe 42 is fluidly coupled to the heat exchanger 26. In some embodiments, the heat transfer fluid circuit 24 is a single-use disposable circuit. In some embodiments, the secondary circuit pump 40 is part of the heater / cooler module 22. In some embodiments, the secondary circuit pump 36 includes an HLM pump and / or an independent pump. In some embodiments, the second fluid includes water. In some embodiments, the secondary circuit 36 is disposable.

[0072] In some embodiments, the secondary circuit 36 is a closed loop containing the second fluid. In some embodiments, the secondary circuit 36 is an airtight sealed closed loop containing the second fluid. In embodiments where the secondary circuit 36 is a closed loop, the system 20 prevents contamination of the OR due to an open air tank containing the second fluid. Moreover, these embodiments eliminate the need to disinfect the secondary circuit 36.

[0073] In some embodiments, the heat transfer fluid circuit 24 is a reusable circuit that is cleaned and disinfected after one or more uses. In other embodiments, at least a portion of the secondary circuit 36 is part of the heater / cooler module 22 and is non-disposable, such that at least a portion of the secondary circuit 36 is cleaned and disinfected after one or more uses. During disinfection, any residual second fluid in the secondary circuit 36 is drained, and heat disinfection is performed at a temperature such as 95 °C for a specified time to disinfect the circuit, including preventing bacterial growth.

[0074] The main circuit pump 32 in the heater / cooler module 22 pumps a first fluid around and through the main circuit 28, including through the main circuit pipe 34 and the heat exchanger 26. The heater / cooler element 30 is controlled to heat / cool the first fluid. The secondary circuit pump 40, which is part of the heat transfer fluid circuit 24 in some embodiments and part of the heater / cooler module 22 in some embodiments, pumps a second fluid around and through the secondary circuit pipe 42, the target device 38, and the heat exchanger 26. The secondary circuit 36 supplies the second fluid to the target device 38 to heat / cool the target device 38. The main circuit 28 and the secondary circuit 36 are separate circuits such that the first fluid and the second fluid remain separate in the system 20.

[0075] The heat exchanger 26 includes at least a portion of the main circuit 28 through which the first fluid flows and at least a portion of the secondary circuit 36 through which the second fluid flows to facilitate heat transfer between the first fluid and the second fluid. The temperature of the second fluid is regulated by the temperature of the first fluid. In some embodiments, the target device 38 includes a target fluid, and the second fluid flows through the target device 38 to facilitate heat transfer between the second fluid and the target fluid.

[0076] Figure 2 FIG. is a diagram illustrating a stacked modular heating / cooling system 100 including a first modular heating / cooling system 102 and a second modular heating / cooling system 104 according to an embodiment of the present disclosure. The first modular heating / cooling system 102 includes a heater / cooler module 106, a heat transfer fluid circuit 108, and a heat exchanger 110. The second modular heating / cooling system 104 includes a heater / cooler module 112, a heat transfer fluid circuit 114, and a heat exchanger 116. The first modular heating / cooling system 102 includes a power connector 102a that supplies power to the first modular heating / cooling system 102, and the second modular heating / cooling system 104 includes a power connector 104a that supplies power to the second modular heating / cooling system 104. In some embodiments, one or more of the heater / cooler modules 106 and 112 are similar to the heater / cooler module 22. In some embodiments, one or more of the heat transfer fluid circuits 108 and 114 are similar to the heat transfer fluid circuit 24. In some embodiments, one or more of the heat exchangers 110 and 116 are similar to the heat exchanger 26. In other embodiments, the stacked modular heating / cooling system 100 includes a different number of heater / cooler modules, heat transfer fluid circuits, and / or heat exchangers to provide an increase in heating / cooling capacity and / or an increase in heating / cooling channels.

[0077] In some embodiments, each of the first and second modular heating / cooling systems 102 and 104 consumes 500 - 600 watts, such that the stacked modular heating / cooling system 100 consumes 1000 - 1200 watts. In these embodiments, the stacked modular heating / cooling system 100 can be powered via one power outlet (in Europe where one power outlet can supply up to 3.5 kW, in the United States where one power outlet can supply 1.8 kW, and in Japan where one power outlet can supply up to 1.5 kW). Alternatively, each of the first and second modular heating / cooling systems 102 and 104 can be plugged into separate outlets.

[0078] Like Figure 1 system 20, system 100 can be used in different heating / cooling applications in the medical field, including heating / cooling of blood in an oxygenator, heating or cooling of one or more drugs in cardioplegia solution, heating / cooling of clothing or other items (such as blankets, high and low temperature programs), and heating / cooling of fluids in organ perfusion. Moreover, system 100 can be used in CPB and ECMO applications, such as in the ICU.

[0079] The heater / cooler module 106 includes a main circuit 118, and the main circuit 118 includes a heater / cooler element 120 fluidly connected to a main circuit pump 122 via a main circuit pipe 124. The main circuit 118 contains a first fluid, and the main circuit pipe 124 is fluidly connected to a heat exchanger 110. The heater / cooler module 112 includes a main circuit 126, and the main circuit 126 includes a heater / cooler element 128 fluidly connected to a main circuit pump 130 via a main circuit pipe 132. The main circuit 126 contains another first fluid, and the main circuit pipe 132 is fluidly connected to a heat exchanger 116. In some embodiments, one or more of the heater / cooler elements 120 and 128 include a heat pump. In some embodiments, one or more of the main circuit pumps 122 and 130 include an HLM pump and / or an independent pump. In some embodiments, one or more of the first fluids include water. In some embodiments, one or more of the main circuits 118 and 126 are a permanent part of their corresponding heater / cooler modules 106 and 112.

[0080] In some embodiments, one or more of the main circuits 118 and 126 are closed loops containing their corresponding first fluids. In some embodiments, one or more of the main circuits 118 and 126 are airtight sealed closed loops containing their corresponding first fluids. In embodiments, in the case where one or more of the main circuits 118 and 126 are closed loops, the closed loops prevent contamination of the OR due to open gas tanks containing fluids. Moreover, these embodiments eliminate the need to disinfect the closed loop main circuits 118 and 126.

[0081] The heat transfer fluid circuits 108 and 114 include a secondary circuit 134 that includes a target device 136 fluidly coupled to a secondary circuit pump 138 via a secondary circuit pipe 140. The secondary circuit 134 contains a second fluid. The secondary circuit pipe 140 is fluidly coupled to each of the heat exchangers 110 and 116, and the secondary circuit pipe 140 fluidly couples the heat exchanger 110 to the heat exchanger 116. In some embodiments, each of the heat transfer fluid circuits 108 and 114 is a single-use disposable circuit. In some embodiments, the secondary circuit pump 138 is part of at least one of the first and second modular heating / cooling systems 102 and 104. In some embodiments, the secondary circuit pump 138 includes an HLM pump and / or a stand-alone pump. In some embodiments, the second fluid includes water. In some embodiments, the secondary circuit 134 is disposable.

[0082] In some embodiments, the secondary circuit 134 is a closed loop containing the second fluid. In some embodiments, the secondary circuit 134 is an airtight sealed closed loop containing the second fluid. In an embodiment, in the case where the secondary circuit 134 is a closed loop, the system 20 prevents contamination of the OR due to an open gas tank containing the fluid. Moreover, these embodiments eliminate the need to disinfect the secondary circuit 134.

[0083] In some embodiments, one or more of the heat transfer fluid circuits 108 and 114 are reusable circuits that can be cleaned and disinfected after one or more uses. In other embodiments, at least a portion of the secondary circuit 134 is part of one of the heater / cooler modules 106 and 112 and is non-disposable, such that at least a portion of the secondary circuit 134 is cleaned and disinfected after one or more uses. During disinfection, any residual second fluid in the secondary circuit 134 is drained, and heat disinfection is performed at a temperature such as 95 °C for a specified time to disinfect the circuit, which includes preventing bacterial growth.

[0084] The main circuit pump 122 in the heater / cooler module 106 pumps the first fluid around and through the main circuit 118, including through the main circuit pipe 124 and the heat exchanger 110. The heater / cooler element 120 is controlled to heat / cool the first fluid in the main circuit 118.

[0085] The main circuit pump 130 in the heater / cooler module 112 pumps the first fluid around and through the main circuit 126, including through the main circuit pipe 132 and the heat exchanger 116. The heater / cooler element 128 is controlled to heat / cool the first fluid in the main circuit 126.

[0086] In some embodiments, the secondary loop pump 138, which is part of at least one of the heat transfer fluid loops 108 and 114 and in some embodiments part of at least one of the first and second modular heating / cooling systems 102 and 104, pumps a second fluid around and through the secondary loop pipe 140, the target device 136, and the heat exchangers 110 and 116. The secondary loop 134 provides the second fluid to the target device 136 to heat / cool the target device 136. The primary loops 118 and 126 are separate loops such that the first fluid in each remains separate. Moreover, the primary loops 118 and 126 and the secondary loop 134 are separate loops such that each of the first and second fluids remains separate in the system 100.

[0087] The heat exchangers 110 and 116 include at least a portion of the corresponding primary loops 118 and 126 through which the first fluid flows and at least a portion of the secondary loop 134 through which the second fluid flows to facilitate heat transfer between the first and second fluids. The temperature of the second fluid is regulated by the temperature of the first fluid. In some embodiments, the target device 136 includes a target fluid, and the second fluid flows through the target device 136 to facilitate heat transfer between the second fluid and the target fluid.

[0088] Having multiple heater / cooler modules 106 and 112 and multiple heat exchangers 110 and 116 enables the system 100 to heat / cool the target device 136 faster and / or raise / lower the temperature.

[0089] Figure 3A and 3B FIG. is a diagram illustrating another modular heating / cooling system 200 according to an embodiment of the present disclosure. The modular heating / cooling system 200 is similar to Figure 1 system 20. The system 200 includes a heater / cooler module 202, a heat transfer fluid loop 204, and a heat exchanger 206.

[0090] Similar to system 20, different parts of the system 200 (including the heater / cooler module 202, the heat transfer fluid loop 204, and / or the heat exchanger 206) can be "stacked" or coupled to other similar parts to provide an increase in the heating / cooling capacity of the system 200 and / or an increase in the number of heating / cooling channels.

[0091] In most applications, system 200 includes each of heater / cooler module 202, heat transfer fluid circuit 204, and heat exchanger 206, and system 200 consumes 500 - 600 watts. This makes system 200 compatible with portable applications such as ambulance, aircraft, and helicopter applications. Moreover, the low power consumption makes system 200 compatible with battery operation and the use of uninterruptible power supplies (UPS). Additionally, the low power consumption makes system 200 compatible with electrical systems in multiple countries / regions where system 200 can be plugged into a single power outlet without overloading the single power outlet. Thus, system 200 can be used in Europe where a single power outlet can supply up to 3.5 kilowatts, in the United States where a single power outlet can supply 1.8 kilowatts, and in Japan where a single power outlet can supply up to 1.5 kilowatts.

[0092] Modular heating / cooling system 200 also has a size advantage, making it compatible with applications in small areas, such as placing system 200 or components of system 200 near a heart-lung machine (HLM). In some embodiments, system 200 occupies only an area or volume of 0.5 × 0.5 × 0.5 meters. This, together with the low power consumption, makes system 200 suitable for portable applications.

[0093] System 200 can be used in different heating / cooling applications in the medical field, such as heating / cooling of blood in an oxygenator, heating or cooling of one or more drugs in cardioplegia solution, heating / cooling of clothing or other items (such as blankets, high and low temperature procedures), and heating / cooling of fluids in organ perfusion. Additionally, modular heating / cooling system 200 can be used in cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO), such as in an intensive care unit (ICU).

[0094] Figure 3A A diagram illustrating heater / cooler module 202 and heat exchanger 206 according to an embodiment of the present disclosure. In some embodiments, heater / cooler module 202 is similar to one or more of heater / cooler modules 22, 106, and 112. In some embodiments, heat exchanger 206 is similar to heat exchanger 26.

[0095] The heater / cooler module 202 includes an electronic control unit 208 and a main circuit 210 for heating and cooling a first fluid in the main circuit 210. The electronic control unit 208 can be one or more of a controller, a processor, a microcontroller, a microprocessor, and a computer. Moreover, the electronic control unit 208 can include a memory, a user interface (such as a touch screen display) having input and output portions, and executable code stored in the memory, and the electronic control unit 208 executes the executable code to control components of the heater / cooler module 202. The main circuit 210 includes a heating circuit pipe 210a (indicated by diagonal lines on the pipe 210a) in a heating circuit path for heating the first fluid, and a cooling circuit pipe 210b (indicated by a non-diagonal pipe 210b) in a cooling circuit path for cooling the first fluid. In some embodiments, the first fluid includes water. In some embodiments, the main circuit 210 is a permanent part of the heater / cooler module 202.

[0096] In some embodiments, the main circuit 210 including a heating circuit path and a cooling circuit path is a closed loop containing the first fluid. In some embodiments, the main circuit 210 including a heating circuit path and a cooling circuit path is an airtight sealed closed loop containing the first fluid. In embodiments where the main circuit 210 is a closed loop, the system 200 prevents contamination of the OR due to an open gas tank containing the first fluid. Moreover, these embodiments eliminate the need to disinfect the main circuit 210.

[0097] The main circuit 210 includes a heater / cooler element 212, a main circuit pump 214, a portion of the heat exchanger 206, and optionally an auxiliary heat exchanger 218. In some embodiments, the heater / cooler element 212 includes a heat pump. In some embodiments, the main circuit pump 214 includes an HLM pump and / or an independent pump. In some embodiments, the auxiliary heat exchanger 218 receives heat exchanger fluid at 220 and transmits heat exchanger fluid at 222. The heat exchanger fluid is pumped through the auxiliary heat exchanger 218 to facilitate heat transfer between the heat exchanger fluid and the first fluid.

[0098] The main circuit path 210 further includes heating circuit valves 224a and 224b and cooling circuit valves 226a and 226b. Additionally, the main circuit path 210 includes a heating circuit expansion valve 228 and a cooling circuit expansion valve 230. The electronic control unit 208 is electrically connected to the heater / cooler element 212, the main circuit pump 214, the heat exchanger 206, the auxiliary heat exchanger 218, the heating circuit valves 224a and 224b, the cooling circuit valves 226a and 226b, the heating circuit expansion valve 228, and the cooling circuit expansion valve 230 to control the operation of the heater / cooler module 202.

[0099] In the heating circuit path, the heating circuit pipe 210a fluidly couples the following components together: The heater / cooler element 212 is fluidly coupled to the heating circuit valve 224a, which is fluidly coupled to the main circuit pump 214, which is fluidly coupled to the heating circuit valve 224b, which is fluidly coupled to the heat exchanger 206, which is fluidly coupled to the heating circuit expansion valve 228, which is fluidly coupled to the auxiliary heat exchanger 218, which is fluidly coupled to the heater / cooler element 212.

[0100] In the cooling circuit path, the cooling circuit pipe 210b fluidly couples the following components together: The heater / cooler element 212 is fluidly coupled to the cooling circuit expansion valve 230, which is fluidly coupled to the heat exchanger 206, which is fluidly coupled to the cooling circuit valve 226a, which is fluidly coupled to the main circuit pump 214, which is fluidly coupled to the cooling circuit valve 226b, which is fluidly coupled to the auxiliary heat exchanger 218, which is fluidly coupled to the heater / cooler element 212.

[0101] When heating the first fluid, the main circuit pump 214 pumps the first fluid through the heating circuit path (including the heating circuit valve 224b) to the heat exchanger 206, then to the heating circuit expansion valve 228, then to the auxiliary heat exchanger 218, then to the heater / cooler element 212, then to the heating circuit valve 224a and back to the main circuit pump 214. The main circuit pump 214 and the heater / cooler element 212 are controlled by the electronic control unit 208 to heat the first fluid. Additionally, optionally, the auxiliary heat exchanger 218 is controlled, such as by the electronic control unit 208, to heat the first fluid.

[0102] When cooling the first fluid, the main circuit pump 214 pumps the first fluid through the cooling circuit path (including the cooling circuit valve 226b) to the auxiliary heat exchanger 218, then to the heater / cooler element 212, then to the cooling circuit expansion valve 230, then to the heat exchanger 206, then to the cooling circuit valve 226a and back to the main circuit pump 214. The main circuit pump 214 and the heater / cooler element 212 are controlled by the electronic control unit 208 to cool the first fluid. Moreover, optionally, the auxiliary heat exchanger 218 is controlled, such as by the electronic control unit 208, to cool the first fluid.

[0103] The heat exchanger 206 includes at least a portion of a main circuit 210 through which a first fluid flows and at least a portion of a secondary circuit 232 through which a second fluid flows to facilitate heat transfer between the first fluid and the second fluid. The temperature of the second fluid is regulated by the temperature of the first fluid. In some embodiments, the heat exchanger 206 includes a thermoelectric heater / cooler 234 that is thermally coupled to the heat exchanger 206 to heat and / or cool at least one of the first fluid and the second fluid. In some embodiments, the thermoelectric heater / cooler 234 is controlled by an electronic control unit 208. In some embodiments, the target device includes a target fluid, and the second fluid flows through the target device to facilitate heat transfer between the second fluid and the target fluid.

[0104] In some embodiments, the heat exchanger 206 includes one or more auxiliary electric heaters configured to heat the first fluid in the heat exchanger 206. In some embodiments, the heat exchanger 206 includes one or more auxiliary electric heaters configured to heat the second fluid in the heat exchanger 206. In some embodiments, the heat exchanger 206 includes one or more auxiliary electric heaters configured to be used to dry and thermally disinfect the heat exchanger 206 during thermal disinfection. In some embodiments, one or more auxiliary electric heaters in the heat exchanger 206 are controlled by the electronic control unit 208.

[0105] Figure 3B A diagram illustrating a heat transfer fluid circuit 204 and a heat exchanger 206 according to an embodiment of the present disclosure. In some embodiments, the heat transfer fluid circuit 204 is similar to the heat transfer fluid circuit 24.

[0106] The heat transfer fluid circuit 204 includes a secondary circuit 232 that includes a target device 240 fluidly coupled to a second fluid reservoir 242 via a secondary circuit pipe 244. The second fluid is in the secondary circuit 232, and the secondary circuit pipe 244 is fluidly coupled to the heat exchanger 206. A secondary circuit pump 246 pumps the second fluid around the secondary circuit 232 and through the secondary circuit pipe 244 and the heat exchanger 206. The secondary circuit 232 also includes a clamp 248 that prevents / permits fluid flow and / or a vent 250 that vents the secondary circuit pipe 244. In some embodiments, the secondary circuit pump 246 is part of the heat transfer fluid circuit 204. In some embodiments, the secondary circuit pump 246 is part of the heater / cooler module 202. In some embodiments, the target device 240 includes a heat exchanger and a target device fluid such that the heat exchanger facilitates heat transfer between the second fluid and the target device fluid.

[0107] In some embodiments, the target device 240 is an oxygenator that includes a heat exchanger and blood as the fluid of the target device, such that the heat exchanger facilitates heat transfer between the second fluid and the blood to maintain a specified temperature or temperature range of the blood. In some embodiments, the target device 240 includes a first temperature sensor that senses the blood temperature, and the system 200 includes a second temperature sensing device that senses the temperature of the first fluid. In some embodiments, the target device 240 includes a first temperature sensor that senses the blood temperature, and the system 200 includes a second temperature sensing device that senses the temperature of the second fluid. In some embodiments, the target device 240 includes a first temperature sensor that senses the blood temperature, and the system 200 includes a second temperature sensing device that senses the temperature of the first fluid and a third temperature sensing device that senses the temperature of the second fluid. In some embodiments, the first, second, and / or third temperature sensing devices are electrically coupled to the electronic control unit 208. In some embodiments, the system 200 is configured to indicate whether the temperature difference between the blood and at least one of the first fluid and the second fluid is greater than 10 degrees Celsius. In some embodiments, the system 200 is configured to maintain a predetermined temperature offset between the blood and at least one of the first fluid and the second fluid.

[0108] In some embodiments, the heat transfer fluid circuit 204 that includes the secondary loop pump 246 is a single-use disposable circuit. In some embodiments, the heat transfer fluid circuit 204 that does not include the secondary loop pump 246 is a single-use disposable circuit. In some embodiments, the secondary loop 232 that includes the secondary loop pump 246 is disposable. In some embodiments, the secondary loop 232 that does not include the secondary loop pump 246 is disposable. In some embodiments, the second fluid includes water. In some embodiments, the secondary loop pump 246 includes an HLM pump and / or a stand-alone pump. In some embodiments, the secondary loop pump 246 is part of the heat transfer fluid circuit 204. In some embodiments, the secondary loop pump 246 is part of the heater / cooler module 202.

[0109] In some embodiments, the second fluid reservoir 242 is closed. In some embodiments, the second fluid reservoir 242 is a hermetically sealed closed container. In some embodiments, the secondary loop 232 is a closed loop that contains the second fluid. In some embodiments, the secondary loop 232 is a hermetically sealed closed loop that contains the second fluid. In embodiments where the secondary loop 232 is a closed loop, the system 200 prevents contamination of the OR due to an open gas tank that houses the second fluid. Moreover, these embodiments eliminate the need to disinfect the secondary loop 232.

[0110] In some embodiments, the heat transfer fluid circuit 204 is a reusable circuit that is cleaned and disinfected after one or more uses. In other embodiments, at least a portion of the secondary circuit 204 is part of the heater / cooler module 202 and is non-disposable, such that at least a portion of the secondary circuit 232 is cleaned and disinfected after one or more uses. During disinfection, any residual second fluid in the secondary circuit 232 is drained, and heat disinfection is performed at a temperature such as 95 °C for a specified time to disinfect the circuit, including preventing bacterial growth.

[0111] The secondary circuit pump 246 pumps the second fluid around and through the secondary circuit tubing 244, the heat exchanger 206, the target device 240, and into the second fluid reservoir 242 and back to the secondary circuit pump 246. The secondary circuit 232 provides the second fluid to the target device 240 to heat / cool the target device 240. The primary circuit 210 and the secondary circuit 232 are separate circuits such that the first fluid and the second fluid remain separate in the system 200.

[0112] The heat exchanger 206 includes at least a portion of the primary circuit 210 through which the first fluid flows and at least a portion of the secondary circuit 232 through which the second fluid flows to facilitate heat transfer between the first fluid and the second fluid.

[0113] Figure 4A FIG. is a diagram illustrating a heat exchanger 300 according to an embodiment of the present disclosure. The heat exchanger 300 includes a first module 302 and a second module 304. In some embodiments, the first module 302 is part of the primary circuit of the corresponding heater / cooler module such that the first module 302 is a primary circuit module. In some embodiments, the second module 304 is part of the secondary circuit of the corresponding heat transfer fluid circuit such that the second module 304 is a secondary circuit module.

[0114] The first module 302 includes a base 306 that includes a fluid connector 308 that fluidly connects the primary circuit of the corresponding heater / cooler module to the heat exchanger 300. The fluid connector 308 fluidly communicates the first fluid to a coil 310 through which the first fluid flows to achieve a first temperature of the heat exchanger coil 310. The base 306 also includes an O-ring 312 or other means for fixing / sealing the second module 304 to the first module 302 with a fluid or fluid seal to prevent fluid leakage.

[0115] Figure 4BA diagram showing a second module 304 removed from a first module 302 according to an embodiment of the present disclosure. The second module 304 includes a fluid connector 314 that fluidly connects a sub-loop of a corresponding heat transfer fluid circuit to the second module 304. The fluid connector 314 fluidly communicates a second fluid through the second module 304 and around the outside of the coil 310 to facilitate heat transfer between the first fluid and the coil 310 and the second fluid, thereby achieving a second temperature of the second fluid. The second module 304 is fixed to the first module 302 by an O-ring 312 or other means for fixing / sealing the second module 304 to the first module 302 to provide a fluid-tight fit that prevents leakage of the second fluid from the second module 304. In some embodiments, the second module 304 is a disposable module.

[0116] In some embodiments, the first module 302 includes an auxiliary electric heater 316 that is controlled to heat the second fluid. In some embodiments, the auxiliary electric heater 316 is used to dry and thermally disinfect the heat exchanger 300 during thermal disinfection. In some embodiments, the auxiliary electric heater 316 is electrically connected to and controlled by the electronic control unit 208. In some embodiments, the heat exchanger 300, such as the base 306 of the heat exchanger 300, includes an auxiliary heater, such as an auxiliary electric heater, for heating the first fluid. In some embodiments, the heat exchanger 300 includes one or more auxiliary heaters, such as electric heaters or other suitable types of heaters. In some embodiments, the second module 304 includes one or more auxiliary heaters, such as auxiliary electric heaters, that are controlled to heat the second fluid.

[0117] In some embodiments, the first module 302 includes a temperature sensor 318 for measuring the temperature of the heat exchanger 300, such as the temperature of the base 306, in the absence of the second fluid in the second module 304. In some embodiments, the temperature sensor 318 is electrically connected to and read by the electronic control unit 208. In some embodiments, the heat exchanger 300 includes more than one temperature sensor for measuring the temperature of the heat exchanger 300.

[0118] In some embodiments, the first module 302 includes a temperature sensor 320 for measuring the temperature of the second fluid in the second module 304. In some embodiments, the temperature sensor 320 is electrically connected to and read by the electronic control unit 208. In some embodiments, the heat exchanger 300 includes more than one temperature sensor for measuring the temperature of at least one of the first fluid and the second fluid. In some embodiments, the second module 304 includes a temperature sensor for measuring the temperature of the second fluid in the second module 304.

[0119] Figure 5FIG. showing another heat exchanger 350 according to an embodiment of the present disclosure. The heat exchanger 350 includes a heat exchanger structure 352 and a container 354, and the container 354 seals the heat exchanger structure 352 with a fluid-tight connection. In some embodiments, the heat exchanger structure 352 is part of the main circuit of a corresponding heater / cooler module, such that the heat exchanger structure 352 is a main circuit module. In some embodiments, the container 354 is part of a secondary circuit of a corresponding heat transfer fluid circuit, such that the container 354 is a secondary circuit module. In some embodiments, the container 354 is part of a secondary circuit containing a patient's blood or medicine or other fluid. In some embodiments, the container 354 is part of a secondary circuit that directly serves as the heat exchanger of an oxygenator.

[0120] The heat exchanger structure 352 includes a fluid connection 356 that fluidly connects the main circuit of the corresponding heater / cooler module to the heat exchanger structure 352. The fluid connection 356 fluidly communicates a first fluid to the heat exchanger structure 352, and the first fluid flows through the heat exchanger structure 352 to reach a first temperature of the heat exchanger structure 352, that is, the first fluid flowing through the heat exchanger structure 352 promotes heat transfer between the first fluid and the heat exchanger structure 352 to reach the first temperature of the heat exchanger structure 352. In some embodiments, the heat exchanger structure 352 includes a seal (not shown) that fixes the container 354 to the heat exchanger structure 352 with a fluid-tight connection to prevent leakage of a second fluid.

[0121] The container 354 includes a fluid connection 358 that fluidly connects the secondary circuit of the corresponding heat transfer fluid circuit to the container 354. The fluid connection 358 fluidly communicates a second fluid through the container 354 and around the outside of the heat exchanger structure 352 to promote heat transfer between the heat exchanger structure 352 and the second fluid, thereby reaching a second temperature of the second fluid, that is, the second fluid flows through the container 354 and around the heat exchanger structure 352 separated by a heat-conducting material in the container 354 to promote heat transfer between the heat exchanger structure 352 and the second fluid, thereby reaching the second temperature of the second fluid. In some embodiments, the container 354 is a disposable container.

[0122] In some embodiments, the heat exchanger structure 352 includes an auxiliary electric heater 360 that is controlled to heat the second fluid. In some embodiments, the auxiliary electric heater 360 is electrically connected to and controlled by the electronic control unit 208. In some embodiments, the heat exchanger structure 352 includes an auxiliary heater, such as an auxiliary electric heater, that heats the first fluid. In some embodiments, the heat exchanger structure 352 includes one or more auxiliary heaters, such as electric heaters or other suitable types of heaters. In some embodiments, the container 354 includes one or more auxiliary heaters, such as auxiliary electric heaters, that are controlled to heat the second fluid.

[0123] In some embodiments, the heat exchanger structure 352 includes a temperature sensor 362 to measure the temperature of the heat exchanger structure 352 with or without a second fluid in the container 354. In some embodiments, the temperature sensor 362 is electrically coupled to and read by the electronic control unit 208. In some embodiments, the heat exchanger 350 includes more than one temperature sensor to measure the temperature of the heat exchanger structure 352.

[0124] In some embodiments, the heat exchanger structure 352 includes a temperature sensor 364 to measure the temperature of the second fluid in the container 354. In some embodiments, the temperature sensor 364 is electrically coupled to and read by the electronic control unit 208. In some embodiments, the heat exchanger 350 includes more than one temperature sensor to measure the temperature of at least one of the first fluid and the second fluid. In some embodiments, the container 354 includes a temperature sensor to measure the temperature of the second fluid in the container 354.

[0125] In some embodiments, the heat exchanger structure 352 includes a temperature sensor 366 to measure the temperature of the first fluid. In some embodiments, the temperature sensor 366 is electrically coupled to and read by the electronic control unit 208.

[0126] Figure 6 FIG. is a diagram illustrating another heat exchanger 400 according to an embodiment of the present disclosure. The heat exchanger 400 includes a first heat exchanger module 402 and a second heat exchanger module 404. In some embodiments, the first heat exchanger module 402 is part of the main loop of a corresponding heater / cooler module, such that the first heat exchanger module 402 is a main loop module. In some embodiments, the second heat exchanger module 404 is part of the secondary loop of a corresponding heat transfer fluid loop, such that the second heat exchanger module 404 is a secondary loop module.

[0127] The first heat exchanger module 402 includes inlet and outlet fluid connectors 406 that fluidly connect the main circuit of the corresponding heater / cooler module to the first heat exchanger module 402. The fluid connectors 406 fluidly communicate a first fluid to the first heat exchanger module 402, and the first fluid flows through the first heat exchanger module 402 to achieve a first temperature of the first heat exchanger module 402. That is, the first fluid flowing through the first heat exchanger module 402 facilitates heat transfer between the first fluid and the first heat exchanger module 402 to achieve the first temperature of the first heat exchanger module 402. The first heat exchanger module 402 includes a flat side 408 that is closest to or adjacent to the second heat exchanger module 404 to facilitate heat transfer between the first heat exchanger module 402 and the second heat exchanger module 404. In some embodiments, the flat side 408 of the first heat exchanger module 402 contacts at least a portion of the second heat exchanger module 404 to facilitate heat transfer between the first heat exchanger module 402 and the second heat exchanger module 404. In some embodiments, the first heat exchanger module 402 includes a labyrinth baffle or structure that circulates the first fluid within the first heat exchanger module 402 to facilitate heat transfer between the first fluid and the first heat exchanger module 402. In some embodiments, the first heat exchanger module 402 is a disposable heat exchanger module. In some embodiments, the first heat exchanger module 402 is a non-disposable heat exchanger module that is part of the corresponding heater / cooler module.

[0128] The second heat exchanger module 404 includes inlet and outlet fluid connectors 410 that fluidly connect a secondary loop fluid of a corresponding heat transfer fluid circuit to the second heat exchanger module 404. The fluid connectors 410 fluidly communicate a second fluid through the second heat exchanger module 404 and through a labyrinth baffle or structure 412 to facilitate heat transfer between the second heat exchanger module 404 and the second fluid, thereby achieving a second temperature of the second fluid, i.e., the second fluid flows through the second heat exchanger module 404 to facilitate heat transfer between the second heat exchanger module 404 and the second fluid, thereby achieving a second temperature of the second fluid. The second heat exchanger module 404 includes a flat side 414 that is closest to or adjacent to the flat side 408 of the first heat exchanger module 402 to facilitate heat transfer between the first heat exchanger module 402 and the second heat exchanger module 404, and then transfer heat to / from the second heat exchanger module to / from the second fluid to achieve a second temperature of the second fluid. In some embodiments, the flat side 408 of the first heat exchanger module 402 contacts at least a portion of the flat side 414 of the second heat exchanger module 404 to facilitate heat transfer between the first heat exchanger module 402 and the second heat exchanger module 404. In some embodiments, the second heat exchanger module 404 is a disposable heat exchanger module. In some embodiments, the second heat exchanger module 404 is a non-disposable heat exchanger module that is part of one of a corresponding heater / cooler module or a corresponding heat transfer loop module. In some embodiments, at least one of the first heat exchanger module 402 and the second heat exchanger module 404 is referred to as a plate heat exchanger or a plate heat exchanger module.

[0129] The first heat exchanger module 402 and the second heat exchanger module 404 include a positioning mechanism 416 that orients and positions the first heat exchanger module 402 and the second heat exchanger module 404 together. In some embodiments, the positioning mechanism 416 includes a safety interlock to prevent operation in the event that the first heat exchanger module 402 and the second heat exchanger module 404 are not properly docked, and in some embodiments provides a warning signal to an operator. In some embodiments, one of the first heat exchanger module 402 and the second heat exchanger module 404 includes pins, such as at one or more corners, and the other includes one or more holes that are configured to receive the one or more pins for placement. In some embodiments, the dimensions of the positioning mechanism 416 (such as positioning pins) are detected by the electronic control unit 308 and used to adapt the performance parameters of the system to the particular first and / or second heat exchanger modules 402 and 404 being used.

[0130] In some embodiments, the heat exchanger 400 includes one or more auxiliary heaters, such as the auxiliary electric heater 418, to heat the second fluid, and in some embodiments, to more precisely regulate the amount of energy transferred to the target device and / or the patient. In some embodiments, at least one of the auxiliary electric heaters 418 is located between the first heat exchanger module 402 and the second heat exchanger module 404 and is controlled to transfer heat to the second heat exchanger module 404 and the second fluid. In some embodiments, at least one of the auxiliary electric heaters is located above or within one or more of the first heat exchanger modules 402 and is controlled to transfer heat to the second fluid. In some embodiments, the first heat exchanger module 402 includes at least one auxiliary heater, such as the auxiliary electric heater 418, to heat the first fluid. In some embodiments, the second heat exchanger module 404 includes at least one auxiliary heater, such as the auxiliary electric heater 418, to heat the second fluid. In some embodiments, at least one of the auxiliary electric heaters 418 can be used to dry and thermally disinfect one or more of the first and second heat exchanger modules 402 and 404 during thermal disinfection. In some embodiments, at least one of the auxiliary electric heaters 418 is electrically connected to and controlled by an electronic control unit, such as the electronic control unit 208. In some embodiments, one or more of the auxiliary heaters are auxiliary heater / coolers that transfer heat to and / or from the second fluid, such as Peltier-type heater / coolers.

[0131] In some embodiments, the heat exchanger 400 includes one or more temperature sensors 420 to measure the temperature of at least one of the first fluid and the second fluid. In some embodiments, the heat exchanger 400 includes at least one temperature sensor 420 located near at least one of the inlet and outlet fluid connectors 406 to measure the temperature of the first fluid. In some embodiments, the heat exchanger 400 includes at least one temperature sensor 420 located near at least one of the inlet and outlet fluid connectors 410 to measure the temperature of the second fluid, wherein the temperature measurement of the second fluid at the outlet fluid connector 410 measures the temperature of the fluid flowing to the target device, and the temperature of the second fluid at the inlet fluid connector 410 can be used to measure or calculate the amount of energy transferred to the target device. In some embodiments, the heat exchanger 400 includes one or more temperature sensors 420 configured to measure the temperature of at least one of the first and second heat exchanger modules 402 and 404 with or without fluid in at least one of the first and second heat exchanger modules 402 and 404. In some embodiments, one or more of the temperature sensors 420 are electrically connected to and read by the electronic control unit 208. In some embodiments, the temperature sensors 420 extend into the first and / or second heat exchanger modules 402 and 404 to measure the temperature of the first and / or second fluid, respectively.

[0132] Figure 7 FIG. is a flowchart illustrating a method of heating / cooling a target fluid in a target device via a heater / cooler module according to an embodiment of the present disclosure. The heater / cooler module includes a first fluid in a main loop, a pump, a heater / cooler element, and a heat exchanger.

[0133] At 500, the method includes pumping a first fluid through the main loop and the heat exchanger via a pump. At 502, the method includes heating / cooling the first fluid in the main loop with a heater / cooler element. In some embodiments, the heater / cooler element includes a heat pump. In some embodiments, heating / cooling the first fluid includes heating / cooling the first fluid in the main loop with an auxiliary heat exchanger in the heater / cooler module, wherein the auxiliary heat exchanger is configured to receive a third fluid to facilitate heat transfer between the third fluid and the first fluid in the main loop. In some embodiments, heating / cooling the first fluid includes heating / cooling the first fluid in the main loop with a thermoelectric heater / cooler coupled to the heat exchanger, such as a Peltier heater / cooler.

[0134] At 504, the method includes providing a second fluid in a secondary loop separate from the primary loop such that the first fluid and the second fluid are maintained as separate fluids. At 506, the method includes pumping the second fluid through the secondary loop and a heat exchanger, and at 508, facilitating heat transfer in the heat exchanger between the second fluid in the secondary loop and the first fluid in the primary loop. In some embodiments, facilitating heat transfer between the second fluid in the secondary loop and the first fluid in the primary loop includes pumping the first fluid through a heat exchanger coil that is part of the primary loop and located in the heat exchanger, and pumping the second fluid through a container sealed around the heat exchanger coil such that the second fluid flows around the heat exchanger coil. In some embodiments, facilitating heat transfer between the second fluid in the secondary loop and the first fluid in the primary loop includes pumping the first fluid through a heat exchanger structure that is part of the primary loop and located in the heat exchanger, and pumping the second fluid through a container sealed around the heat exchanger structure such that the second fluid flows around the heat exchanger structure. In some embodiments, facilitating heat transfer between the second fluid in the secondary loop and the first fluid in the primary loop includes pumping the first fluid through a first plate heat exchanger that is part of the primary loop and located in the heat exchanger, pumping the second fluid through a second plate heat exchanger that is part of the secondary loop and a heat transfer fluid loop, and facilitating heat transfer between the first plate heat exchanger and the second plate heat exchanger to heat / cool the second fluid.

[0135] At 510, the method includes providing the second fluid to a target device to facilitate heat transfer between the second fluid and a target fluid. In some embodiments, the method further includes heating at least one of the first fluid in the heat exchanger and the second fluid in the heat exchanger with one or more auxiliary electric heaters coupled to the heat exchanger.

[0136] Without departing from the scope of the present disclosure, various modifications and additions can be made to the exemplary embodiments discussed. For example, although the above embodiments relate to specific features, the scope of the present disclosure also includes embodiments having different combinations of the features and embodiments that do not include all of the features. Accordingly, the scope of the present disclosure is intended to cover all such alternatives, modifications, and variations, and all equivalents thereof, that fall within the scope of the claims.

Claims

1. A system for heating or cooling a patient's blood during a procedure involving extracorporeal blood circulation, the system comprising: a heater / cooler module including a first pump and a first heater / cooler element fluidly coupled to a main circuit, the main circuit including a heating circuit tube in a heating circuit path and a separate cooling circuit tube in a cooling circuit path and configured to heat and / or cool a first fluid in the main circuit, wherein each of the separate heating and cooling circuit paths is fluidly coupled to the first heater / cooler element; a heat transfer fluid circuit including a secondary circuit configured to supply a second fluid to a target device containing blood therein to heat and / or cool the blood; and a heat exchanger including at least a portion of the main circuit through which the first fluid flows and at least a portion of the secondary circuit through which the second fluid flows to facilitate heat transfer between the first fluid and the second fluid, wherein the main circuit and the secondary circuit are separate circuits such that the first fluid and the second fluid remain separate in the system.

2. The system according to claim 1, wherein the main circuit is a permanent part of the heater / cooler module and at least a portion of the secondary circuit is disposable.

3. The system according to claim 1 or 2, wherein the heat transfer fluid circuit is a single-use disposable circuit.

4. The system according to claim 1, comprising at least one of the following: two or more heat exchangers; two or more heater / cooler modules; and two or more heat transfer fluid circuits.

5. The system according to claim 1, comprising two or more heat exchangers, two or more heater / cooler modules, and two or more heat transfer fluid circuits.

6. The system according to claim 1, wherein the heat exchanger includes one or more temperature sensors configured to measure the temperature of the heat exchanger.

7. The system according to claim 1, wherein the target device includes an oxygenator and a heat exchanger.

8. The system according to claim 7, comprising a first temperature sensor configured to measure the temperature of the blood and a second temperature sensor configured to measure the temperature of at least one of the first fluid and the second fluid, wherein the system is configured to maintain a predetermined temperature offset between the blood and at least one of the first fluid and the second fluid.

9. The system according to claim 1, wherein the heat exchanger comprises: a first module configured to receive the first fluid and a disposable module configured to receive the second fluid, and wherein the first module includes one or more auxiliary electric heaters to heat at least one of the first fluid and the second fluid, or includes a temperature sensor configured to measure the temperature of at least one of the first fluid and the second fluid.

10. The system according to claim 9, wherein the disposable module includes one or more auxiliary electric heaters to heat at least one of the first fluid and the second fluid.

11. A system for heating or cooling a patient's blood during a procedure involving extracorporeal blood circulation, the system comprising: A heater / cooler module including a first pump and a first heater / cooler element fluidly coupled to a main circuit, the main circuit including a heating circuit tube in a heating circuit path and a separate cooling circuit tube in a cooling circuit path, and configured to heat and / or cool a first fluid in the main circuit, wherein each of the separate heating and cooling circuit paths is fluidly coupled to the first heater / cooler element such that when heated by the first heater / cooler element, the first fluid flows from the first heater / cooler element into the heating circuit path, and when cooled by the first heater / cooler element, the first fluid flows from the first heater / cooler element into the cooling circuit path; A heat transfer fluid circuit including: a secondary circuit configured to provide a second fluid to a target device containing blood to heat and / or cool the blood of the target device; And A heat exchanger including at least a portion of the main circuit through which the first fluid flows and at least a portion of the secondary circuit through which the second fluid flows to facilitate heat transfer between the first fluid and the second fluid, wherein the main circuit and the secondary circuit are separate circuits such that the first fluid and the second fluid remain separate in the system.

12. The system according to claim 11, wherein, The heating circuit path is fluidly connected between the first heater / cooler element and the first pump.

13. The system according to claim 12, wherein, The cooling circuit path is fluidly connected between the first heater / cooler element and the first pump.

14. The system according to claim 11, wherein the heat exchanger comprises: A first module configured to receive the first fluid and a disposable module configured to receive the second fluid, and wherein the first module includes one or more auxiliary electric heaters to heat at least one of the first fluid and the second fluid, or includes a temperature sensor configured to measure the temperature of at least one of the first fluid and the second fluid.

15. The system according to claim 14, wherein, The disposable module includes one or more auxiliary electric heaters to heat at least one of the first fluid and the second fluid.

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