Patent Description:
Oxygenators are devices used for extracorporeal oxygenation of blood. Often, oxygenators are used in heart-lung machines or extracorporeal membrane oxygenation (ECMO) devices, which include membrane oxygenators that can avoid embolisms to a large extent. With the aid of gas mixers and flow meters the transfer of oxygen and carbon dioxide is reliably controlled.

In an oxygenator, a patient's blood is warmed or cooled and oxygenated. The oxygenator optionally includes a heat exchanger for warming or cooling the blood. In the oxygenator, a heat exchanging medium flows through the heat exchanger and transfers a heat quantity to the blood for warming the blood or absorbs a heat quantity from the blood for cooling the blood. The heat exchanging medium is usually supplied to the heat exchanger by a pump unit and, after heat exchange with the blood has taken place, the heat exchanging medium is discharged from the heat exchanger by the same pump unit or another pump unit. The heat exchanging medium, e.g. water, glycol, or combinations of these or other fluids, is previously heated or cooled in a heater/cooler before it is conducted to the heat exchanger. Due to its size and complex structure, the heater/cooler is separate from the heart-lung machine or ECMO.

In some situations, the heat exchange medium of the heater/cooler and system configurations rely on reusing the heater/cooler fluids or media, allow for the unintended reuse of heater/cooler fluids or media, or depend on a user or operator to follow proper cleaning and maintenance instructions or protocols. If the operator does not follow proper instructions or protocols, these situations may create the potential for the build-up of contaminates and potentially harmful microorganisms in the heater/cooler fluids or media. Also, the heater/cooler may be over powered for most applications and present power consumption and power supply compatibility issues. In addition, due to its large size, the heater/cooler may have limited usability and may not be transportable. Also, due to its size to power ratio the heater/cooler may not be suited for intensive care unit (ICU) applications.

The present invention provides systems for heating/cooling a target unit as defined in the appended claims.

As recited in examples, example <NUM> is a system for heating/cooling a target unit. The system includes a heater/cooler unit and a heat transfer fluid module. The heater/cooler unit includes a heater/cooler that includes a heater/cooler element and a heater/cooler pump, and a heat exchanger that includes a heat exchange element. The heater/cooler pump pumps a first fluid through the heater/cooler element and the heat exchange element and back to the heater/cooler pump. The heat transfer fluid module includes a fluid reservoir with a second fluid that is pumped to and through the heat exchanger to transfer heating/cooling between the first fluid and the second fluid and pumped to and through the target unit to transfer heating/cooling between the second fluid and the target unit.

Example <NUM> is the system of Example <NUM>, wherein the heater/cooler pump, the heater/cooler element, and the heat exchange element are a closed circuit containing the first fluid.

Example <NUM> is the system of Examples <NUM> or <NUM>, wherein the heater/cooler pump, the heater/cooler element, and the heat exchange element are a hermetically sealed closed circuit containing the first fluid and configured to prevent contamination of the second fluid and an operating room.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heat transfer fluid module is a disposable heat transfer fluid module.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heat transfer fluid module includes the fluid reservoir and a heat transfer fluid pump configured to pump the second fluid from the fluid reservoir to the heat exchanger and the target unit and back to the fluid reservoir.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heat transfer fluid pump is a reversible pump configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heat exchanger includes a heat transfer fluid pump configured to pump the second fluid from the fluid reservoir to the heat exchanger and the target unit and back to the fluid reservoir.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, comprising an integrated thermal disinfection system around the heat exchanger to provide heat to disinfect the heat exchanger.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heat exchanger is emptied of the second fluid and hot disinfected by the thermal disinfection system at a higher temperature for a period to sterilize the heat exchanger and prevent bacterial growth.

Example <NUM> is a system for heating/cooling a target unit. The system including a heater/cooler unit and a heat transfer fluid module. The heater/cooler unit configured to regulate temperature of a first fluid and pump the first fluid through a heat exchanger in a closed circuit that prevents contamination due to the first fluid. The heat transfer fluid module including a fluid reservoir and a heat transfer fluid pump that pumps a second fluid from the fluid reservoir to the heat exchanger and the target unit and back to the fluid reservoir to regulate temperature of the second fluid and the target unit.

Example <NUM> is the system of Example <NUM>, wherein the heat transfer fluid module includes the fluid reservoir, the heat transfer fluid pump, and a pass though tube configured to pass the second fluid from the heat exchanger to the target unit.

Example <NUM> is the system of Example <NUM> or <NUM>, wherein the heat transfer fluid pump is a reversible pump configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heat transfer fluid pump is a reversible pump including a flexible impeller having flexible blades and configured to bend the flexible blades counter to a direction of the impeller inside the heat transfer fluid pump.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, comprising an integrated thermal disinfection system surrounding at least some of the heat exchanger and configured to thermally disinfect the heat exchanger at a higher temperature for a specified time to sterilize the heat exchanger.

Example <NUM> is the system of any of Examples <NUM>-<NUM>, wherein the heater/cooler unit includes a drive motor configured to drive the heat transfer fluid pump.

Example <NUM> is a method of heating/cooling a target fluid in a target unit using a heater/cooler unit and a heat transfer fluid module. The heater/cooler unit including a heater/cooler pump, a heater/cooler element, and a heat exchanger and the heat transfer fluid module including a fluid reservoir. The method including: pumping a first fluid, using the heater/cooler pump, through the heater/cooler element and the heat exchanger and back to the heater/cooler pump in a closed circuit; heating/cooling the first fluid with the heater/cooler element; pumping a second fluid from the fluid reservoir and through the heat exchanger and the target unit and back to the fluid reservoir, such that the first fluid and the second fluid are maintained as separate fluids; wherein pumping the second fluid facilitates heat transfer in the heat exchanger between the first fluid and the second fluid and heat transfer between the second fluid and the target fluid in the target unit.

Example <NUM> is the method of Example <NUM>, wherein pumping the second fluid comprises one of pumping the second fluid using a heat transfer fluid pump situated in the heat transfer fluid module and pumping the second fluid using a heat transfer fluid pump situated in the heat exchanger.

Example <NUM> is the method of Example <NUM> or <NUM>, wherein pumping the second fluid comprises pumping the second fluid using a reversible pump, the method further comprising reversing the reversible pump to drain the heat exchanger and disinfecting the drained heat exchanger using a thermal disinfection system.

Example <NUM> is a system including a heater/cooler unit, a fluid reservoir, and a fluid pump. The heater/cooler unit is configured to regulate temperature of a first fluid and pump the first fluid through a heat exchanger in a closed circuit. The fluid pump pumps a second fluid from the fluid reservoir to the heat exchanger and a target unit and back to the fluid reservoir to regulate temperature of the second fluid and the target unit. The fluid pump is a reversible pump including an impeller having flexible blades that bend in a direction opposite to a direction of spin of the impeller in the fluid pump.

Example <NUM> is the system of Example <NUM>, wherein the reversible pump is configured to drain the second fluid from the heat exchanger and return the second fluid to the fluid reservoir.

While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure.

While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications and alternatives falling within the scope of the disclosure as defined by the appended claims.

<FIG> is a diagram illustrating a modular heating/cooling system <NUM>, according to embodiments of the disclosure. The heating/cooling system <NUM> includes a heater/cooler unit <NUM>, a disposable heat transfer fluid module <NUM>, and a target unit <NUM>.

The disposable heat transfer fluid module <NUM> provides the advantage of being disposable, such that the heat transfer fluid module <NUM> including the heat transfer fluid in the heat transfer fluid module <NUM> is disposed of to eliminate or reduce the build-up of contaminates and potentially harmful microorganisms in the system. In embodiments, the disposable heat transfer fluid module <NUM> is a single use module. In embodiments, the heat transfer fluid module <NUM> includes a transponder, such as transponder <NUM> discussed below, or a radio frequency identification (RFID) tag that identifies the heat transfer fluid module <NUM> to the system <NUM>. The transponder or RFID tag can be used to limit the number of uses of the heat transfer fluid module <NUM> including the heat transfer fluid.

The target unit <NUM> can include a heat exchanger and, in some embodiments, the target unit <NUM> includes an oxygenator that includes a heat exchanger. Also, in embodiments, the target unit <NUM> is located at a target location that may be adjacent the heat transfer fluid module <NUM>, remote from the heat transfer fluid module <NUM>, and/or separate from the heat transfer fluid module <NUM>. In some embodiments, the target unit <NUM> is at a target location adjacent the heat transfer fluid module <NUM>. In some embodiments, the target unit <NUM> is at a target location remote from the heat transfer fluid module <NUM>. In embodiments where the target unit <NUM> is at a target location remote from the heat transfer fluid module <NUM>, the system may use tubing, for example, as illustrated in <FIG>.

The different parts of the system <NUM>, including the heater/cooler unit <NUM>, the heat transfer fluid module <NUM>, and/or the target unit <NUM>, can be coupled to other similar parts to provide an increase in the heating/cooling capability of the system <NUM> and/or to increase the number of heating/cooling channels. For example, multiple heater/cooler units <NUM> may be connected together in series or in parallel and/or multiple heat transfer fluid modules <NUM> may be connected together in series or in parallel and/or multiple target units <NUM> may be connected together in series or in parallel to provide an increase in heating/cooling capability and/or an increase in heating/cooling channels. Also, having multiple similar parts provides redundancy in case of failure of any of the parts, and modularity allows the system <NUM> to be customized to fit different power consumption needs and to provide optimized heating/cooling capabilities, as required for different applications.

In most applications, the system <NUM> includes one of each of the heater/cooler unit <NUM>, the heat transfer fluid module <NUM>, and/or the target unit <NUM>.

In these embodiments, the system <NUM> consumes <NUM>-<NUM> watts, which makes the system <NUM> compatible with portable applications, such as ambulance, aircraft, and helicopter applications. Also, low power consumption makes the system <NUM> compatible with battery operation and with the use of uninterruptible power supplies (UPS's). In addition, low power consumption makes the system <NUM> compatible with electrical systems in multiple countries, where the system <NUM> can be plugged into one power outlet without overpowering the single outlet. Thus, the system <NUM> can be used in Europe where one electrical power outlet may supply up to <NUM> kilowatts, and in the United States where one power outlet may supply <NUM> kilowatts, and in Japan where one power outlet may supply only up to <NUM> kilowatts.

Also, the heating/cooling system <NUM> has size advantages making it compatible with applications in small areas, such as placing the system <NUM> or components of the system <NUM> near a heart lung machine (HLM). In some embodiments, the system <NUM> takes up an area or volume of only <NUM> x <NUM> x <NUM> meters. This, along with the low power consumption, makes the system <NUM> available for portable applications, including patient transport in a hospital environment.

The system <NUM> can be used in different heating/cooling applications in the medical field. These medical field applications include heating/cooling of the blood in an oxygenator, heating/cooling of a drug or drugs in cardioplegia, heating/cooling of clothing or other items such as blankets, hyperthermia and hypothermia procedures, and the heating/cooling of fluids in organ perfusion. In addition, the heating/cooling system <NUM> can be used in cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO), such as in an intensive care unit (ICU).

The heater/cooler unit <NUM> includes a heater/cooler <NUM> and an integrated heat exchanger <NUM> fluidically coupled to the heater/cooler <NUM> by heater/cooler tubing <NUM>. The heater/cooler <NUM> includes a heater/cooler element <NUM> fluidically coupled to a heater/cooler pump <NUM> via the heater/cooler tubing <NUM>. The integrated heat exchanger <NUM> includes a heater/cooler heat exchange element <NUM> that is fluidically coupled to the heater/cooler element <NUM> and the heater/cooler pump <NUM> via the heater/cooler tubing <NUM>. The heater/cooler pump <NUM> pumps a first fluid through the heater/cooler element <NUM> and the heater/cooler tubing <NUM> to and from the heat exchange element <NUM> in the integrated heat exchanger <NUM>. In some embodiments, the heater/cooler element <NUM> includes one or more of a heat pump, a resistance heating element, or a thermoelectric heating element. In some embodiments, the heater/cooler pump <NUM> includes a pump of an HLM and/or a standalone pump. In some embodiments, the first fluid is or includes water, glycol, or combinations of these or other fluids. In some embodiments, the heater/cooler <NUM> is a permanent part of the heater/cooler unit <NUM>.

In other embodiments, the heater/cooler <NUM> can be directly connected to the integrated heat exchanger <NUM>, such as by a flange or an extension on one unit that fits into a receptacle on the other unit. In embodiments, these direct connections may reduce the size and footprint of the system. Also, in some embodiments, the heater/cooler <NUM> can be thermally connected to the integrated heat exchanger <NUM> such as by heat conducting plates or thermal radiation and not through a first fluid and tubing.

In some embodiments, the heater/cooler tubing <NUM>, the heater/cooler element <NUM>, the heater/cooler pump <NUM>, and the heat exchange element <NUM> are a closed circuit containing the first fluid that flows through the heater/cooler <NUM> and the heat exchange element <NUM> in the integrated heat exchanger <NUM>. In some embodiments, the heater/cooler tubing <NUM>, the heater/cooler element <NUM>, the heater/cooler pump <NUM>, and the heat exchange element <NUM> are a hermetically sealed closed circuit containing the first fluid. In embodiments where the heater/cooler tubing <NUM>, the heater/cooler element <NUM>, the heater/cooler pump <NUM>, and the heat exchange element <NUM> are a closed circuit, the system <NUM> prevents contamination of the OR due to open air tanks holding the first fluid. Also, these embodiments reduce or eliminate the need for disinfecting the heater/cooler tubing <NUM>, the heater/cooler element <NUM>, the heater/cooler pump <NUM>, and the heat exchange element <NUM> in the integrated heat exchanger <NUM>.

The heat transfer fluid module <NUM> includes a heat transfer fluid tank <NUM> that includes a heat transfer fluid reservoir <NUM>, a heat transfer fluid pump <NUM>, and a heat transfer fluid pass through tube <NUM>. In some embodiments, the heat transfer fluid module <NUM> is a single use disposable module. In some embodiments, the heat transfer fluid pump <NUM> includes a pump of an HLM and/or a standalone pump. In some embodiments, the heat transfer fluid pump <NUM> is a reversible pump. In some embodiments, the heat transfer fluid pump <NUM> is part of the integrated heat exchanger <NUM> in the heater/cooler unit <NUM>. In some embodiments, the heat transfer fluid pass through tube <NUM> is not part of the heat transfer fluid tank <NUM>.

The heat transfer fluid module <NUM> is fluidically coupled to the heater/cooler unit <NUM> by quick connects/disconnects 128a and 128b, such that the heat transfer fluid pass through tube <NUM> is fluidically coupled to the integrated heat exchanger <NUM> through tubing <NUM> and quick connect/disconnect 128a, and the heat transfer fluid pump <NUM> is fluidically coupled to the integrated heat exchanger <NUM> by tubing <NUM> and quick connect/disconnect 128b.

In other embodiments, the heat transfer fluid module <NUM> can be directly connected to the heater/cooler unit <NUM> and the integrated heat exchanger <NUM>. In some embodiments, the heat transfer fluid module <NUM> can be directly connected to the heater/cooler unit <NUM> and the integrated heat exchanger <NUM>, such as by the quick connects/disconnects 128a and 128b. In some embodiments, the heat transfer fluid module <NUM> can be directly connected to the heater/cooler unit <NUM> and the integrated heat exchanger <NUM>, such as by a flange or an extension on one unit that fits into a receptacle on the other unit. In some embodiments, the quick connects/disconnects 128a and 128b can be snap fit mechanisms having a release button for releasably connecting the heat transfer fluid module <NUM> to the integrated heat exchanger <NUM>. The heat transfer fluid module <NUM> is fluidically coupled to the target unit <NUM> by quick connects/disconnects 134a and 134b, such that the heat transfer fluid pass through tube <NUM> is fluidically coupled to the target unit <NUM> through tubing <NUM> and quick connect/disconnect 134a, and the heat transfer fluid reservoir <NUM> is fluidically coupled to the target unit <NUM> through tubing <NUM> and quick connect/disconnect 134b.

In other embodiments, the heat transfer fluid module <NUM> can be directly connected to the target unit <NUM>, such as by the quick connects/disconnects 128a and 128b, or such as by a flange or an extension on one unit that fits into a receptacle on the other unit. In some embodiments, the quick connects/disconnects 128a and 128b can be snap fit mechanisms having a release button for releasably connecting the heat transfer fluid module <NUM> to the target unit <NUM>.

The heat transfer fluid reservoir <NUM> contains or is filled with a second heat transfer fluid that is pumped through the integrated heat exchanger <NUM>, the heat transfer fluid pass through tube <NUM>, the target unit <NUM>, and back to the heat transfer fluid reservoir <NUM> by the heat transfer fluid pump <NUM>. In embodiments, the heat transfer fluid pump <NUM> is a reversible pump, such that the second fluid can be drained from the integrated heat exchanger <NUM> and/or the target unit <NUM> and returned to the heat transfer fluid reservoir <NUM>. The heat transfer fluid module <NUM> can then be disconnected and disposed of, which prevents contamination of the OR due to open air tanks holding the second fluid. In some embodiments, the second fluid is or includes water, glycol, or combinations of these or other fluids.

In embodiments, an integrated thermal disinfection system <NUM> surrounds the integrated heat exchanger <NUM> and provides heat to disinfect the integrated heat exchanger <NUM>. In disinfecting, the integrated heat exchanger <NUM> is emptied of any residual second fluid and hot disinfected at a temperature, such as <NUM> C, for a specified time to sterilize the integrated heat exchanger <NUM>, which includes the prevention of bacterial growth.

In operation, the heater/cooler pump <NUM> pumps the first fluid through the heater/cooler element <NUM> and the heater/cooler tubing <NUM> to and from the heat exchange element <NUM> in the integrated heat exchanger <NUM>. The heater/cooler element <NUM> is controlled to heat/cool the first fluid. Also, the heat transfer fluid pump <NUM>, which in some embodiments is part of the integrated heat exchanger <NUM> in the heater/cooler unit <NUM>, pumps the second fluid from the heat transfer fluid reservoir <NUM> through the integrated heat exchanger <NUM>, the heat transfer fluid pass through tube <NUM>, the target unit <NUM>, and back to the heat transfer fluid reservoir <NUM>.

The first fluid and the second fluid remain separated in the system <NUM>, and the temperature of the second fluid is regulated by the temperature of the first fluid. The second fluid is heated/cooled by the heat exchange element <NUM>, where the first fluid flows through the heat exchange element <NUM>. In embodiments, the second fluid flows through the integrated heat exchanger <NUM> making physical contact with the heat exchange element <NUM>. In embodiments, a different type of integrated heat exchanger <NUM> can be used to transfer heating/cooling from the first fluid to the second fluid and keep the first and second fluids separated.

In some embodiments, a different type of integrated heat exchanger <NUM> can be used, such as one or more of the heat exchangers described in publication number WO/<NUM>/<NUM> having international application number <CIT>, titled "MODULAR HEATER COOLER WITH DISPOSABLE HEAT TRANSFER FLUID CIRCUIT' filed October <NUM>, <NUM>.

The second fluid flows through the target unit <NUM> to heat/cool the target unit <NUM>. In some embodiments, the target unit <NUM> includes a target fluid and the second fluid flows through the target unit <NUM> to facilitate heat transfer between the second fluid and the target fluid. In embodiments, the target unit <NUM> includes or is an oxygenator including a heat exchanger for heating/cooling blood, such that the second fluid flows through the heat exchanger of the oxygenator to heat/cool the blood, which is the target fluid.

In some embodiments, the target unit <NUM> includes or is an oxygenator fluidically connected to a patient <NUM> by blood fluid lines 139a and 139b. The oxygenator includes a heat exchanger that receives blood from the patient <NUM> as the target fluid and that receives the second fluid. In embodiments, the blood flows from the patient <NUM> and through the blood fluid line 139a to the oxygenator, including to the heat exchanger in the oxygenator, and the blood flows through the blood fluid line 139b from the oxygenator and the heat exchanger back to the patient <NUM>. The temperature of the blood is regulated by heat transfer between the second fluid and the blood in the heat exchanger of the oxygenator.

<FIG> is a diagram illustrating another modular heating/cooling system <NUM>', according to embodiments of the disclosure. The heating/cooling system <NUM>' is the same as the heating/cooling system <NUM> except the heat transfer fluid pump <NUM> has been moved from the heat transfer fluid tank <NUM> in the disposable heat transfer fluid module <NUM> to the integrated heat exchanger <NUM> in the heater/cooler unit <NUM>. Thus, the heating/cooling system <NUM>' includes a heat transfer fluid tank <NUM>' in a disposable heat transfer fluid module <NUM>' that does not include the heat transfer fluid pump <NUM> and an integrated heat exchanger <NUM>' in a heater/cooler unit <NUM>' that does include the heat transfer fluid pump <NUM>. The other numbered components in <FIG> are the same in form and function as like numbered components in <FIG>, and the heating/cooling system <NUM>' functions and operates the same as the heating/cooling system <NUM>.

<FIG> is a diagram illustrating a heater/cooler unit <NUM> including a heater/cooler <NUM> and an integrated heat exchanger <NUM>, according to embodiments of the disclosure. In embodiments, the heater/cooler unit <NUM> is similar to the heater/cooler unit <NUM> (shown in <FIG>) or the heater/cooler unit <NUM>' (shown in <FIG>). In some embodiments, the heater/cooler <NUM> is similar to the heater/cooler <NUM> and, in some embodiments, the heat exchanger <NUM> is similar to the integrated heat exchanger <NUM> (shown in <FIG>) or the integrated heat exchanger <NUM>' (shown in <FIG>).

The heater/cooler <NUM> includes an electronic control unit <NUM> and a primary circuit <NUM> for heating and cooling the first fluid in the primary circuit <NUM>. The electronic control unit <NUM> can be one or more of a controller, a processor, a micro-controller, a micro-processor, and a computer. Also, the electronic control unit <NUM> can include memory, a user interface having input and output portions, such as a touch screen display, and executable code stored in memory that the electronic control unit <NUM> executes to control the components of the heater/cooler <NUM>. The primary circuit <NUM> includes heating circuit tubing <NUM> Oa, indicated by slashes on the tubing 21Oa, in a heating circuit path for heating the first fluid, and cooling circuit tubing <NUM> Ob, indicated with non-slashed tubing <NUM> Ob, in a cooling circuit path for cooling the first fluid. In some embodiments, the first fluid includes water. In some embodiments, the primary circuit <NUM> is a permanent part of the heater/cooler <NUM>.

In some embodiments, the primary circuit <NUM>, including the heating circuit path and the cooling circuit path, is a closed circuit containing the first fluid. In some embodiments, the primary circuit <NUM>, including the heating circuit path and the cooling circuit path, is a hermetically sealed closed circuit containing the first fluid. In embodiments where the primary circuit <NUM> is a closed circuit, the heater/cooler unit <NUM> prevents contamination of the OR due to open air tanks holding the first fluid. Also, these embodiments eliminate the need for disinfecting the primary circuit <NUM>.

The primary circuit <NUM> includes a heater/cooler element <NUM>, a heater/cooler primary circuit pump <NUM>, part of the heat exchanger <NUM> and, optionally, an auxiliary heat exchanger <NUM>. In some embodiments, the heater/cooler element <NUM> includes a heat pump. In some embodiments, the primary circuit pump <NUM> includes a pump of an HLM and/or a standalone pump. In some embodiments, the auxiliary heat exchanger <NUM> receives a heat exchanger fluid at <NUM> and transmits the heat exchanger fluid at <NUM>. The heat exchanger fluid is pumped through the auxiliary heat exchanger <NUM> to facilitate heat transfer between the heat exchanger fluid and the first fluid.

The primary circuit path <NUM> also includes heating circuit valves 224a and 224b and cooling circuit valves 226a and 226b. In addition, the primary circuit path <NUM> includes a heating circuit expansion valve <NUM> and a cooling circuit expansion valve <NUM>. The electronic control unit <NUM> is electrically coupled to the heater/cooler element <NUM>, the primary circuit pump <NUM>, the heat exchanger <NUM>, the auxiliary heat exchanger <NUM>, the heating circuit valves 224a and 224b, the cooling circuit valves 226a and 226b, the heating circuit expansion valve <NUM>, and the cooling circuit expansion valve <NUM> to control operation of the heater/cooler <NUM>.

In the heating circuit path, the heating circuit tubing 21Oa fluidically couples the following components together: the heater/cooler element <NUM> is fluidically coupled to the heating circuit valve 224a that is fluidically coupled to the primary circuit pump <NUM> that is fluidically coupled to the heating circuit valve 224b that is fluidically coupled to the heat exchanger <NUM> that is fluidically coupled to the heating circuit expansion valve <NUM> that is fluidically coupled to the auxiliary heat exchanger <NUM> that is fluidically coupled to the heater/cooler element <NUM>.

In the cooling circuit path, the cooling circuit tubing 21Ob fluidically couples the following components together: the heater/cooler element <NUM> is fluidically coupled to the cooling circuit expansion valve <NUM> that is fluidically coupled to the heat exchanger <NUM> that is fluidically coupled to the cooling circuit valve 226a that is fluidically coupled to the primary circuit pump <NUM> that is fluidically coupled to the cooling circuit valve 226b that is fluidically coupled to the auxiliary heat exchanger <NUM> that is fluidically coupled to the heater/cooler element <NUM>.

In heating the first fluid, the primary circuit pump <NUM> pumps the first fluid through the heating circuit path including the heating circuit valve 224b to the heat exchanger <NUM> to the heating circuit expansion valve <NUM> to the auxiliary heat exchanger <NUM> to the heater/cooler element <NUM> to the heating circuit valve 224a and back to the primary circuit pump <NUM>. The primary circuit pump <NUM> and the heater/cooler element <NUM> are controlled by the electronic control unit <NUM> to heat the first fluid. Also, optionally, the auxiliary heat exchanger <NUM> is controlled, such as by the electronic control unit <NUM>, to heat the first fluid.

In cooling the first fluid, the primary circuit pump <NUM> pumps the first fluid through the cooling circuit path including the cooling circuit valve 226b to the auxiliary heat exchanger <NUM> to the heater/cooler element <NUM> to the cooling circuit expansion valve <NUM> to the heat exchanger <NUM> to the cooling circuit valve 226a and back to the primary circuit pump <NUM>. The primary circuit pump <NUM> and the heater/cooler element <NUM> are controlled by the electronic control unit <NUM> to cool the first fluid. Also, optionally, the auxiliary heat exchanger <NUM> is controlled, such as by the electronic control unit <NUM>, to cool the first fluid.

The heat exchanger <NUM> includes a heat exchange element, such as heat exchange element <NUM>, that is part of the primary circuit <NUM> through which the first fluid flows. The heat exchanger <NUM> also includes part of a secondary circuit <NUM> through which a second fluid flows to facilitate heat transfer between the first fluid and the second fluid in the heat exchanger <NUM>. The temperature of the second fluid is regulated by the temperature of the first fluid. In some embodiments, the heat exchanger <NUM> includes a thermoelectric heater/cooler <NUM> thermally coupled to the heat exchanger <NUM> to heat and/or cool at least one of the first fluid and the second fluid. In some embodiments, the thermoelectric heater/cooler <NUM> is controlled by the electronic control unit <NUM>. In some embodiments, a target unit, such as target unit <NUM>, includes a target fluid and the second fluid flows through the target unit to facilitate heat transfer between the second fluid and the target fluid.

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

<FIG> are diagrams illustrating an exemplary heat transfer fluid tank <NUM>, according to embodiments of the disclosure. The fluid tank <NUM> can be used in the heat transfer fluid module <NUM> (shown in <FIG>). In embodiments, the fluid tank <NUM> is similar to the heat transfer fluid tank <NUM> (shown in <FIG>).

<FIG> is a diagram illustrating a perspective view of the heat transfer fluid tank <NUM>, according to embodiments of the disclosure. The fluid tank <NUM> includes a heat transfer fluid reservoir <NUM>, a reversible heat transfer fluid pump <NUM>, and a heat transfer fluid pass through tube <NUM>. The fluid tank <NUM> also includes connections for connecting the fluid tank <NUM> to other modules, such as the heater/cooler unit <NUM> and the target unit <NUM>. In some embodiments, the heat transfer fluid tank <NUM> includes a transponder <NUM> for wireless communications to a base system for identifying the fluid tank <NUM> to the base system and preventing off label use, e.g., reuse of the fluid tank <NUM> instead of replacement. In some embodiments, the fluid reservoir <NUM> is similar to the heat transfer fluid reservoir <NUM>. In some embodiments, the fluid pump <NUM> is similar to the heat transfer fluid pump <NUM>. In some embodiments, the fluid pass through tube <NUM> is similar to the heat transfer fluid pass through tube <NUM>.

The heat transfer fluid tank <NUM> as shown in the figures is shaped like a rectangular prism or rectangular box having a flat bottom <NUM>, such that the fluid tank <NUM> is stable standing upright. In other embodiments, the fluid tank <NUM> can be another suitable shape such as cylindrical, cuboid, or a triangular prism.

The heat transfer fluid reservoir <NUM> as shown in the figures is shaped like a rectangular prism or rectangular box with a reservoir bottom <NUM> that is angled down from the back <NUM> of the fluid tank <NUM> to the front <NUM> of the fluid tank <NUM>. This angled reservoir bottom <NUM> causes the fluid in the fluid reservoir <NUM> to flow to the deeper front portion of the fluid reservoir <NUM>. Also, the angled reservoir bottom <NUM> makes room outside the fluid reservoir <NUM> for the heat transfer fluid pass through tube <NUM> to be attached to the fluid tank <NUM>.

The heat transfer fluid reservoir <NUM> includes a body <NUM> and a top <NUM> that is secured to and sealed to the body <NUM>. The fluid tank <NUM> further includes a fill cap <NUM> that is removably secured to the top <NUM>, such as by screwing or turning the fill cap <NUM> into a fill cap location <NUM> in the top <NUM>. The fluid reservoir <NUM> is filled with heat transfer fluid through the fill cap location <NUM> in the top <NUM> and the fill cap <NUM> is then secured to the top <NUM>.

The top <NUM> further includes a target unit connection <NUM> for connecting the fluid tank <NUM> to a target unit, such as target unit <NUM>, and a heater/cooler connection <NUM> for connecting the fluid tank <NUM> to a heater /cooler module, such as heater/cooler unit <NUM>. The target unit connection <NUM> is fluidically coupled to or formed integral with a fluid return tube <NUM> that is internal to the fluid reservoir <NUM> and extends toward the bottom of the fluid reservoir <NUM>.

The heat transfer fluid pump <NUM> is secured to the top <NUM> and fluidically coupled to the heater/cooler connection <NUM>. Also, the fluid pump <NUM> is fluidically coupled to an internal fluid pick-up tube <NUM> that extends to the deeper front bottom portion of the heat transfer fluid reservoir <NUM>. The fluid pump <NUM> includes a drive shaft <NUM> configured to be coupled to a drive motor, which may be a drive motor that is part of a heater/cooler unit, which turns the drive shaft <NUM> in forward and reverse directions as needed.

In embodiments, one end of the heat transfer fluid pass through tube <NUM> includes a heater/cooler connection <NUM> that is fluidically coupled to an integrated heat exchanger, such as the integrated heat exchanger <NUM>, and the other end, indicated at <NUM>, of the heat transfer fluid pass through tube <NUM> is fluidically coupled to a target unit, such as target unit <NUM>. The heat transfer fluid pump <NUM> is fluidically coupled to the integrated heat exchanger through the other heater/cooler connection <NUM> and the target unit connection <NUM> is fluidically coupled to the target unit.

In operation, the heat transfer fluid tank <NUM> is fluidically coupled to a heater/cooler unit, such as heater/cooler unit <NUM>, and fluidically coupled to a target unit, such as target unit <NUM>. The heat transfer fluid reservoir <NUM> is filled with a heat transfer fluid through the fill cap location <NUM> in the top <NUM> and the fill cap <NUM> is secured to the top <NUM>. The heat transfer fluid pump <NUM> is driven in a forward direction to draw heat transfer fluid through the internal fluid pick-up tube <NUM> and pump the heat transfer fluid from the fluid reservoir <NUM> out of the heater/cooler connection <NUM> and through the integrated heat exchanger and the heat transfer fluid pass through tube <NUM> to a target unit. The heat transfer fluid returns from the target unit to the fluid reservoir <NUM> through the target unit connection <NUM> and the fluid return tube <NUM>.

In embodiments, to drain or empty the heat transfer fluid from the connected modules, such as the heater/cooler unit <NUM> and the target unit <NUM>, the target unit is disconnected from the target unit connection <NUM> and the heat transfer fluid pump <NUM> is driven in a reverse direction to pull the heat transfer fluid from the integrated heat exchanger and the target unit and back into the fluid reservoir <NUM> through the internal fluid pick-up tube <NUM>. The heat exchanger, such as the integrated heat exchanger <NUM>, can then be disinfected.

<FIG> is a diagram illustrating a front view of the heat transfer fluid tank <NUM>, according to embodiments of the disclosure, and <FIG> is a diagram illustrating a back view of the heat transfer fluid tank <NUM>, according to embodiments of the disclosure. The front view illustrated in <FIG> shows the front <NUM> of the fluid tank <NUM> and the back view illustrated in <FIG> shows the back <NUM> of the fluid tank <NUM>.

In reference to <FIG> and <FIG>, the heat transfer fluid tank <NUM> includes the heat transfer fluid reservoir <NUM>, the reversible heat transfer fluid pump <NUM>, and the heat transfer fluid pass through tube <NUM>. The fluid reservoir <NUM> includes the body <NUM> and the top <NUM>, and the fluid tank <NUM> includes the fill cap <NUM> removably secured to the top <NUM> at the fill cap location <NUM>. Also, the fluid reservoir <NUM> is filled with heat transfer fluid up to the dashed line <NUM>.

The top <NUM> includes the target unit connection <NUM> for connecting the fluid tank <NUM> to a target unit and the heater/cooler connection <NUM> for connecting the fluid tank <NUM> to a heater/cooler unit. The target unit connection <NUM> is fluidically coupled to the fluid return tube <NUM> and the heater/cooler connection <NUM> is fluidically coupled to the heat transfer fluid pump <NUM> that is fluidically coupled to the internal fluid pick-up tube <NUM>. The fluid pump <NUM> includes the drive shaft <NUM> configured to be coupled to a drive motor that turns the drive shaft <NUM> in forward and reverse directions.

In further reference to <FIG> and <FIG>, the heat transfer fluid tank <NUM> has a front view profile that is rectangular and a back view profile that is rectangular. The back view profile includes the angled reservoir bottom <NUM> that makes room for the heat transfer fluid pass through tube <NUM> outside the fluid reservoir <NUM>. The fluid pass through tube <NUM> includes the target unit connection <NUM> and the heater/cooler connection <NUM>. The target unit connection <NUM> of the top <NUM> and the target unit connection <NUM> of the pass through tube <NUM> are each connected to tubing <NUM> that is further connected to the target unit. In embodiments, the fluid pass through tube <NUM> is attached to the fluid tank <NUM> at one end by an attachment mechanism <NUM> and at the other end by a second attachment mechanism <NUM>. In other embodiments, the fluid pass through tube <NUM> can be attached to the fluid tank <NUM> in other ways, such as by inserting the tube <NUM> through a cavity and clamping the tube <NUM> in place.

<FIG> is a diagram illustrating a side view of the heat transfer fluid tank <NUM>, according to embodiments of the disclosure, and <FIG> is a diagram illustrating a top view of the heat transfer fluid tank <NUM>, according to embodiments of the disclosure. The heat transfer fluid tank <NUM> has a side view profile that is rectangular and a top view profile that is rectangular. Each of the views of <FIG> and <FIG> show the front <NUM> and the back <NUM> of the fluid tank <NUM>. The side view illustrated in <FIG> shows the side with the heat transfer fluid pump <NUM> of the fluid tank <NUM>, and the top view illustrated in <FIG> shows the top <NUM> of the fluid tank <NUM>.

In reference to <FIG> and <FIG>, the heat transfer fluid tank <NUM> includes the heat transfer fluid reservoir <NUM>, the reversible heat transfer fluid pump <NUM>, and the heat transfer fluid pass through tube <NUM>. The fluid reservoir <NUM> includes the body <NUM> and the top <NUM>, and the fluid tank <NUM> includes the fill cap <NUM> removably secured to the top <NUM>. Also, the fluid reservoir <NUM> is filled with heat transfer fluid up to the dashed line <NUM>.

The top <NUM> includes the target unit connection <NUM> for connecting the fluid tank <NUM> to a target unit and the heater/cooler connection <NUM> for connecting the fluid tank <NUM> to a heater/cooler unit. The heater/cooler connection <NUM> is fluidically coupled to the heat transfer fluid pump <NUM> that is fluidically coupled to the internal fluid pick-up tube <NUM>. The fluid pump <NUM> includes the drive shaft <NUM> configured to be coupled to a drive motor that turns the drive shaft <NUM> in forward and reverse directions.

<FIG> is a diagram illustrating a cross-section view of the heat transfer fluid tank <NUM> taken along the line A-A in <FIG>, according to embodiments of the disclosure. The heat transfer fluid tank <NUM> includes the heat transfer fluid reservoir <NUM>, the reversible heat transfer fluid pump <NUM>, and the heat transfer fluid pass through tube <NUM>. The fluid reservoir <NUM> includes the body <NUM> and the top <NUM> and is filled with heat transfer fluid up to the line at <NUM>.

The top <NUM> includes the target unit connection <NUM> for connecting the fluid tank <NUM> to a target unit and the heater/cooler connection <NUM> for connecting the fluid tank <NUM> to a heater/cooler unit. The target unit connection <NUM> is fluidically coupled to tubing <NUM> and to the fluid return tube <NUM> and the heater/cooler connection <NUM> is fluidically coupled to the heat transfer fluid pump <NUM> that is fluidically coupled to the internal fluid pick-up tube <NUM>. Also, the fluid pass through tube <NUM> includes the heater/cooler connection <NUM> and tubing <NUM> connected to the target unit connection <NUM> (not shown in <FIG>).

The fluid pump <NUM> includes the drive shaft <NUM> that is configured to be coupled to a drive motor that turns the drive shaft <NUM> in forward and reverse directions. As seen in the cross section, the fluid pump <NUM> includes a pump front <NUM> secured to a pump casing <NUM> by devices <NUM>, such as screws. The drive shaft <NUM> includes an internal drive shaft portion <NUM> that is attached to an impeller <NUM>. The drive shaft portion <NUM> extends through the pump front <NUM> and to the end of the drive shaft <NUM>, which is configured to be coupled to a drive motor. The drive shaft <NUM> is turned by the drive motor, which turns the impeller <NUM> to pump the heat transfer fluid in and out of the fluid reservoir <NUM>.

<FIG> is a diagram illustrating a cross-section view of the heat transfer fluid tank <NUM> taken along the line B-B in <FIG>, according to embodiments of the disclosure. Briefly, the heat transfer fluid tank <NUM> includes the heat transfer fluid reservoir <NUM>, the reversible heat transfer fluid pump <NUM>, and the heat transfer fluid pass through tube <NUM>. The fluid reservoir <NUM> includes the body <NUM> and the top <NUM> and is filled with heat transfer fluid up to the line at <NUM>.

The top <NUM> includes the target unit connection <NUM> for connecting the fluid tank <NUM> to a target unit and the fill cap <NUM>. The target unit connection <NUM> is fluidically coupled to tubing <NUM> and to the fluid return tube <NUM> and the heater/cooler connection <NUM> (not shown in <FIG>) is fluidically coupled to the heat transfer fluid pump <NUM> that is fluidically coupled to the internal fluid pick-up tube <NUM>. Also, the fluid pass through tube <NUM> includes the target unit connection <NUM> connected to tubing <NUM>.

The fluid pump <NUM> includes the pump casing <NUM> and the impeller <NUM> secured to the internal drive shaft portion <NUM>. The impeller <NUM> includes flexible impeller blades <NUM> that are turned inside the pump casing <NUM> to pump the heat transfer fluid in and out of the fluid reservoir <NUM>.

<FIG> is a diagram illustrating the impeller <NUM> of the heat transfer fluid pump <NUM>, according to embodiments of the disclosure. The impeller <NUM> includes the flexible impeller blades <NUM>, an impeller body <NUM>, and impeller teeth <NUM>. The impeller <NUM> includes a flexible material, such as rubber or plastic. In embodiments, the impeller <NUM> is made from a flexible material, such as rubber or plastic. In some embodiments, the impeller <NUM> including the impeller blades <NUM>, the impeller body <NUM>, and the impeller teeth <NUM> are formed as one integrated unit in a molding process.

The impeller body <NUM> has a circular profile with the impeller teeth <NUM> connected to or integral with the impeller body <NUM> and spaced apart around the interior circumference of the impeller body <NUM>. The impeller <NUM> is inserted onto the internal drive shaft portion <NUM> of the drive shaft <NUM>, such that the impeller teeth <NUM> mate with corresponding drive shaft teeth <NUM> (as shown in <FIG>) on the internal drive shaft portion <NUM>. Thus, the impeller <NUM> spins with the drive shaft <NUM> and the impeller teeth <NUM> and drive shaft teeth <NUM> prevent the impeller <NUM> from slipping on the drive shaft <NUM>.

The flexible impeller blades <NUM> are connected to or integral with the impeller body <NUM> and spaced apart around the exterior circumference of the impeller body <NUM>. The impeller blades <NUM> turn inside the pump casing, such as pump casing <NUM>, to pump the heat transfer fluid in and out of the fluid reservoir <NUM>.

<FIG> is a diagram illustrating the impeller <NUM> spinning counter-clockwise in a pump casing <NUM>, according to embodiments of the disclosure. The impeller <NUM> is securely fit or mounted on a drive shaft <NUM> that is spinning in the counter-clockwise direction.

The pump casing <NUM> includes a pump body <NUM>, a first port <NUM>, and a second port <NUM>. The pump body <NUM> has an interior cavity <NUM>, such that each of the first port <NUM> and the second port <NUM> has a hole through it that extends from the interior cavity <NUM> and through the pump body <NUM> and each of the ports <NUM> and <NUM> to outside the pump casing <NUM>. The interior cavity <NUM> has a generally circular interior circumference with a flattened portion <NUM> near the first port <NUM> and the second port <NUM>.

In operation, as the impeller <NUM> spins in the counter-clockwise direction, the impeller blades <NUM> are bent clockwise at the flattened portion <NUM> to expel or push fluid out of the second port <NUM>. Also, as the impeller blades <NUM> spin in the counter-clockwise direction, the impeller blades <NUM> leave the flattened portion <NUM> and extend out to the circular interior circumference of the pump casing <NUM> to create suction and pull fluid into the first port <NUM>.

<FIG> is a diagram illustrating the impeller <NUM> spinning clockwise in the pump casing <NUM>, according to embodiments of the disclosure. The impeller <NUM> is mounted on the drive shaft <NUM> that is spinning in a clockwise direction.

In operation, as the impeller <NUM> spins in the clockwise direction, the impeller blades <NUM> are bent counter-clockwise at the flattened portion <NUM> to expel or push fluid out of the first port <NUM>. Also, as the impeller blades <NUM> spin in the clockwise direction, the impeller blades <NUM> leave the flattened portion <NUM> and extend out to the circular interior circumference of the pump casing <NUM> to create suction and pull fluid into the second port <NUM>.

<FIG> is a diagram illustrating the heat transfer fluid tank <NUM> connected to tubing <NUM> for connecting the fluid tank <NUM> to a target unit, according to embodiments of the disclosure. In embodiments, the target unit is target unit <NUM> (shown in <FIG>).

The heat transfer fluid tank <NUM> includes the heat transfer fluid reservoir <NUM>, the reversible heat transfer fluid pump <NUM>, and the heat transfer fluid pass through tube <NUM>. The fluid reservoir <NUM> includes the body <NUM> and the top <NUM>, and the fluid reservoir <NUM> is filled with heat transfer fluid up to the dashed line <NUM>.

The top <NUM> includes the target unit connection <NUM> for connecting the fluid tank <NUM> to a target unit and the heater/cooler connection <NUM> for connecting the fluid tank <NUM> to a heater/cooler unit. The target unit connection <NUM> is fluidically coupled to the fluid return tube <NUM> and the heater/cooler connection <NUM> is fluidically coupled to the heat transfer fluid pump <NUM> that is fluidically coupled to the internal fluid pick-up tube <NUM>.

The fluid pump <NUM> includes the drive shaft <NUM> configured to be coupled to a drive motor <NUM> that turns the drive shaft <NUM> in forward and reverse directions. In embodiments, the drive shaft <NUM> includes teeth that engage corresponding teeth in a motor drive shaft connector <NUM>. In embodiments, the drive motor <NUM> is part of a heater/cooler unit, such as heater/cooler unit <NUM>.

The target unit connection <NUM> is connected to a first length 342a of the tubing <NUM> (e.g., a coil of tubing), such as by an interference fit. This secures the first length 342a of the tubing <NUM> to the target unit connection <NUM> in a watertight or fluid-tight fit. Also, the target unit connection <NUM> (not shown in <FIG>) of the pass through tube <NUM> is connected to a second length 342b of the tubing <NUM> (e.g., a coil of tubing), such as by interference fit, to secure the second length 342b of the tubing <NUM> to the target unit connection <NUM> in a watertight or fluid-tight fit. In embodiments each of the first length of tubing 342a and the second length of tubing 342b is up to <NUM> meters in length.

A clamp <NUM> is slid onto or attached to each of the first and second coils 342a and 342b of the tubing <NUM> to clamp the tubing <NUM> to the target unit in a watertight or fluid-tight manner.

<FIG> is a diagram illustrating the clamp <NUM> on the tubing <NUM> in a closed position, according to embodiments of the disclosure. The clamp <NUM> has been squeezed together to lock the clamp <NUM> in place at the end of the tubing <NUM>.

<FIG> is a diagram illustrating the clamp <NUM> in an open position, according to embodiments of the disclosure. The clamp <NUM> includes a circular portion <NUM> that has a first clamp portion <NUM> at one end and a second clamp portion <NUM> at the other end of the circular portion <NUM>. Each of the first and second clamp portions <NUM> and <NUM> is a c-shaped claw configured to engage the other clamp portion. The first clamp portion <NUM> includes a serrated or teethed top portion <NUM> and a smooth bottom portion <NUM>, and the second clamp portion <NUM> includes a smooth top portion <NUM> and a serrated or teethed bottom portion <NUM>.

To close the clamp <NUM>, the serrated top portion <NUM> of the first clamp portion <NUM> is slid between the top and bottom portions <NUM> and <NUM> of the second clamp portion <NUM>, and the serrated bottom portion <NUM> of the second clamp portion <NUM> is slid between the top and bottom portions <NUM> and <NUM> of the first clamp portion <NUM>. The serrated or teethed top portion <NUM> of the first clamp portion <NUM> engages the serrated or teethed bottom portion <NUM> of the second clamp portion <NUM> to secure the clamp <NUM> in the closed position.

<FIG> is a flow chart diagram illustrating an exemplary method of heating/cooling a target fluid, such as blood, in a target unit <NUM> using the heating/cooling systems <NUM> and <NUM>' of <FIG> and <FIG>, according to embodiments of the disclosure.

At <NUM>, the method includes providing a heater/cooler unit <NUM>/<NUM>' including a heater/cooler pump <NUM>, a heater/cooler element <NUM>, and a heat exchanger <NUM>/<NUM>'. At <NUM>, the method includes providing a disposable heat transfer fluid module <NUM>/<NUM>' including a fluid reservoir <NUM>.

At <NUM>, the method includes fluidically coupling the heat exchanger <NUM>/<NUM>' of the heater/cooler unit <NUM>/<NUM>' to the fluid reservoir <NUM> of the heat transfer fluid module <NUM>/<NUM>'. In embodiments, the heat exchanger <NUM>/<NUM>' of the heater/cooler unit <NUM>/<NUM>' is connected to the fluid reservoir <NUM> of the heat transfer fluid module <NUM>/<NUM>' by tubing <NUM>. In embodiments, the heat exchanger <NUM>/<NUM>' of the heater/cooler unit <NUM>/<NUM>' is directly connected to the fluid reservoir <NUM> of the heat transfer fluid module <NUM>/<NUM>'. In some embodiments, the heat exchanger <NUM>/<NUM>' of the heater/cooler unit <NUM>/<NUM>' is directly connected to the fluid reservoir <NUM> of the heat transfer fluid module <NUM>/<NUM>' by quick connects/disconnects, such as by one or more of quick connects/disconnects 128a and 128b. In some embodiments, the heat exchanger <NUM>/<NUM>' of the heater/cooler unit <NUM>/<NUM>' is directly connected to the fluid reservoir <NUM> of the heat transfer fluid module <NUM>/<NUM>', such as by a flange or an extension on one unit that fits into a receptacle on the other unit. In some embodiments, one or more of the quick connects/disconnects is a snap fit mechanism having a release button for releasably connecting the heater/cooler unit <NUM> and the heat transfer fluid module <NUM>.

At <NUM>, the method includes pumping a first fluid, using the heater/cooler pump <NUM> in the heater/cooler unit <NUM>, through the heater/cooler element <NUM> to the heat exchange element <NUM> in the integrated heat exchanger <NUM> and back to the heater/cooler pump <NUM>. The heater/cooler element <NUM> is controlled to heat/cool the first fluid.

At <NUM>, the method includes pumping a second fluid in the disposable heat transfer fluid module <NUM> from the heat transfer fluid reservoir <NUM> and through the integrated heat exchanger <NUM>, which facilitates heat transfer between the first fluid and the second fluid. The second fluid is further pumped from the integrated heat exchanger <NUM> through the pass through tube <NUM> to the target unit <NUM> and back to the heat transfer fluid reservoir <NUM>.

The first fluid and the second fluid remain separated in the integrated heat exchanger <NUM> and the temperature of the second fluid is regulated by the temperature of the first fluid. In some embodiments, the second fluid flows through the integrated heat exchanger <NUM> making physical contact with the heat exchange element <NUM>. In other embodiments, a different type of integrated heat exchanger <NUM> is used to transfer heating/cooling from the first liquid to the second fluid and keep the first and second fluids separated.

The second fluid flows through the target unit <NUM> to heat/cool the target fluid, such as blood, in the target unit <NUM>. The second fluid flows through the target unit <NUM> to facilitate heat transfer between the second fluid and the target fluid. In embodiments, the target unit <NUM> includes or is an oxygenator including a heat exchanger for heating/cooling blood, such that the second fluid flows through the heat exchanger of the oxygenator to heat/cool the blood and the second fluid is maintained separate from the target fluid.

At <NUM>, the method includes reversing the heat transfer fluid pump <NUM> to drain or empty the second fluid from at least the heat exchanger <NUM>/<NUM>'. Reversing the heat transfer fluid pump <NUM> pulls the second fluid from the heat exchanger <NUM>/<NUM>' and, if connected, from the target unit <NUM> to drain or empty the second fluid from the heat exchanger <NUM>/<NUM>' and, if connected, the target unit <NUM>. The second fluid is returned to the fluid reservoir <NUM>. In embodiments, the input <NUM> to the fluid reservoir <NUM> from the target unit <NUM> is closed off, such as by a valve (not shown), prior to reversing the heat transfer fluid pump <NUM>. In embodiments, the target unit <NUM> is disconnected at quick connect/disconnect 134b and this closes off the disconnect 134b, prior to reversing the heat transfer fluid pump <NUM>. In some embodiments, step <NUM> is not performed.

At <NUM>, the method includes disconnecting the fluid reservoir <NUM> from the heat exchanger <NUM>/<NUM>' and the heater/cooler unit <NUM>/<NUM>'. At <NUM>, the method includes thermally disinfecting the drained integrated heat exchanger <NUM>/<NUM>' using the integrated thermal disinfection system <NUM>. Where, the thermal disinfection system <NUM> surrounds the integrated heat exchanger <NUM>/<NUM>' and provides heat to disinfect the integrated heat exchanger <NUM>/<NUM>'. In embodiments, the drained or emptied integrated heat exchanger <NUM>/<NUM>' is hot disinfected at a temperature, such as <NUM> C, for a specified time to sterilize the integrated heat exchanger <NUM>/<NUM>', which includes the prevention of bacterial growth.

Claim 1:
A system for heating/cooling a target unit, the system comprising:
a heater/cooler unit (<NUM>) including:
a heater/cooler (<NUM>) that includes a heater/cooler element (<NUM>) and a heater/cooler pump (<NUM>); and
a heat exchanger (<NUM>) that includes a heat exchange element (<NUM>), wherein the heater/cooler pump (<NUM>) is configured to pump a first fluid through the heater/cooler element (<NUM>) and the heat exchange element (<NUM>) and back to the heater/cooler pump (<NUM>); and
characterised by
a heat transfer fluid module (<NUM>) including a heat transfer fluid tank (<NUM>, <NUM>) that defines a fluid reservoir (<NUM>, <NUM>) configured to contain a second fluid for pumping to and through the heat exchanger to transfer heating/cooling between the first fluid and the second fluid and for pumping to and through a target unit (<NUM>) to transfer heating/cooling between the second fluid and the target unit.