Patent Description:
This invention relates to a system for cooling the brain of a human subject.

Initial traumatic brain injury (TBI) may cause immediate damage to cerebral structure, neurons, or vasculature. Secondary injuries that follow TBI may include ischemia, swelling, cerebral edema, and increased intracranial pressure. In general, these secondary complications may lead to reduction in the supply of oxygenated blood to the brain (brain ischemia) which may lead to neurodegeneration. In addition to TBI, brain ischemia may be caused by stroke, cardiac arrest, and respiratory failure, the three leading causes of death in the United States.

The secondary injury mechanism following a traumatic event generally results in cell death from lack of blood and will typically begin after about <NUM> minutes of disrupted blood supply. Prolonged oxygen deprivation may cause failure of autoregulation and programmed cell death. Thus, it is important that intervention is performed within the first <NUM> hours after the initial injury.

Evidence suggests that selectively cooling the brain temperature to about <NUM>-<NUM> (therapeutic hypothermia), (See e.g., <NPL>)) or maintaining brain temperature in the normal range (target temperature management) early in the therapeutic window, e.g., less than about <NUM> minutes after injury, may delay necrotic cell death and apoptotic cell death. This may lead to positive effects including, inter alia, a lower cerebral metabolism which reduces harmful metabolic byproduct build up resulting from inadequate blood flow, reduced cerebral oxygen requirements, prevention of neurogenic fever, reduced intracranial pressure (ICP) encephalitis, and the like.

There are currently Class <NUM> and Class <NUM> recommendations for therapeutic hypothermia (TH) and target temperature management (TTM) after certain ischemic brain injuries. Target temperature management and therapeutic hypothermia has been indicated for several ischemic injuries and evidence. See, e.g., <NPL>), <NPL>), and <NPL>). All Class I Level of Evidence (LOE) B - Class III LOE C points towards increased favorable outcomes, reduced length of ICU stay, and improved neurological function at about <NUM> months after injury.

One conventional system for cooling tissue is disclosed in <CIT> Disclosed in the '<NUM> patent application is a system which relies on forced air that is not cooled. Even if the '<NUM> patent application is capable of cooling the forced are, the mask apparatus as taught by the '<NUM> patent application may not provide sufficient cooling to cool the brain of a human subject. Additionally, the '<NUM> patent application fails to teach any feedback to provide any type of control over a cooling process.

Another conventional method and device for non-invasive cerebral systemic cooling is disclosed in <CIT>.

The '<NUM> patent application teaches a complicated and cumbersome cooling device and method which relies inserting an elongated member into a nasal cavity of a patient, injecting a perfluorocarbon spray and a gas into the nasal cavity, and using the gas to enhance evaporation of the perfluorocarbon to reduce the temperature of the brain or infusing a cooled liquid through a complicated three-part cooling assembly with a balloon and two elongated tubes placed inside the nose.

Studies on the effectiveness of brain temperature management after traumatic brain injury is extremely limited. Due to the technological limitation of conventional systems and methods, the evidence in support of conventional systems and methods to address TTM and TH exhibit at least the following drawbacks: studies examine whole body cooling rather than selective cooling of the brain which may have adverse side effects such as shivering, cooling may not be initiated within <NUM> minutes of injury, and consistent cooling and rewarming protocols are not followed.

<CIT> discloses a head cooling system including a source of compressed breathable gas, a vortex tube with an inlet, and a hot gas outlet and a cold gas outlet where the inlet is connected to a source of compressed breathable gas. The system includes an interface for delivering cool gas to a nasopharyngeal cavity in fluid communication with the gas outlet. As disclosed in the '<NUM> patent application the system operates without an external energy supply. <CIT> discloses a brain cooling system which includes a gas delivery subsystem and a cooling apparatus. The gas delivery system may include an apparatus to establish a desired pressure and flow rate for gasses to be inhaled by a subject. The cooling apparatus includes a cooling element disposed within a conduit the cooling element includes a substrate that includes thin sheets of films that are folded and rolled.

Thus, there is a need for a less complex and less cumbersome system and method for cooling the brain that provides a flow of air or breathable gas that cools the brain to effectively provide TH and TTM at the point of injury or prior to hospitalization and early in the therapeutic window, monitors the temperature of the brain and human subject, and adjusts temperature and flow rate of the flow of air or breathable gas to reduce possible adverse side effects which may be associated with cooling the brain of a human subject.

The present invention provides a system for cooling a brain as claimed in claim <NUM>.

The methods of therapy described here below are not claimed and are not part of the present invention.

In one embodiment, the controller may be configured to adjust the temperature and the flow rate of the flow of cooled air or breathable gas to provide therapeutic hypothermic (TH) and/or target temperature management (TTM) to normothermic levels. The controller may be configured to control the flow control device to provide a flow rate of the cooled air or breathable gas at flow rate in the range of about <NUM>/min to about <NUM>/min. The cooling subsystem cooling subsystem may be configured to input the air or breathable gas having a temperature in the range of about -<NUM> to about <NUM>. The controller may be configured to control the cooling subsystem to cool the air or breathable gas and provide the flow of cooled air or breathable gas delivered to the human subject having a temperature in the range of about -<NUM> to about <NUM>. The one or more temperature sensors may include a tympanic sensor or temporal artery sensor. The device adapted to deliver the cooled air or breathable gas to a human subject may include a nasal cannula. The one or more temperature sensors may be adapted to be placed on an end of the nasal cannula. The controller may be configured to control the flow control device to adjust a pressure of the flow of cooled air or breathable gas. The cooling subsystem may include a gas block comprised of a thermally conductive material, the gas block including an inlet configured to input the flow of air or breathable gas and an outlet configured to output the flow of cooled air or breathable gas. The air block may include a plurality of flow channels comprised of the thermally conductive material configured to cool the flow of air or breathable gas and provide and direct the flow of cooled air or breathable gas to the outlet. The cooling subsystem may include a heat transfer subsystem coupled to the gas block and configured as a thermal electric cooling (TEC) device. The controller may be configured to control a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of the flow heating temperature on a side of the TEC in contact with the gas block to heat the source of the flow of air or breathable gas to increase the temperature of the flow of cooled air or breathable gas. The system may include a heat exchange transfer subsystem coupled to the heat transfer subsystem configured to remove heat from the heat transfer subsystem. The heat exchange transfer subsystem may include a conductor block coupled to a side of the TEC and conductive pipes coupled to conductive fins. The system may include a fan coupled to the conductive fins.

In another aspect, a non-claimed method for cooling the brain of a human subject is featured. The method includes receiving a flow of the air or breathable gas. The air or breathable gas is cooled, A flow of cooled air or breathable gas is output to a line coupled to a device adapted to deliver the cooled air or breathable gas to a human subject. A flow rate of the flow of the air or breathable gas and a flow rate of the cooled air or breathable gas output to the line is controlled. At least a flow rate of flow of cooled air or breathable gas is measured. At least a temperature of a brain or a brain correlative site of the human subject and a temperature of the flow of cooled air or breathable gas is measured. A cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas delivered to the human subject is adjusted based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas to cool the brain of the human subject.

In one embodiment, the method may include adjusting the temperature, and the flow rate of the flow of cooled air or breathable gas to provide therapeutic hypothermic (TH) and target temperature management (TTM) to normothermic levels. The method may include providing a flow rate of cooled air or breathable gas at a flow rate in the range of about <NUM> to about <NUM>/m. The method may include receiving the flow of the air or breathable gas having a temperature in the range of about -<NUM> to about <NUM>. The method may include cooling the flow of the air or breathable gas to a temperature in the range of about -<NUM> to about <NUM>. The device adapted to deliver the flow of the air or breathable gas to the human subject may include a nasal cannula. The method may include adjusting a pressure of the flow of cooled air or breathable gas. The method may include providing a gas block comprised of a thermally conductive material, the gas block including an inlet to receive the flow of air or breathable gas and an outlet configured to output the flow of cooled air or breathable gas. The method may include providing a heat transfer subsystem coupled to the gas block configured as a thermal electric cooling (TEC) device. The method may include controlling a current or voltage applied to the TEC to provide a cooling temperature on a side of the TEC in contact with the gas block to cool the source of flow of air or breathable gas and provide a flow of cooled air or breathable gas or to provide a heating temperature on a side of the TEC in contact with the gas block to heat the source of flow of air or breathable gas to increase the temperature of the flow of cooled air or breathable gas. The method may include providing a heat exchange transfer subsystem coupled to the heat transfer system configured to remove heat from the heat transfer subsystem.

The subject invention, however, in other embodiments, need not achieve all these objectives and the claims hereof should not be limited to structures or methods capable of achieving these objectives.

Other objects, features and advantages will occur to those skilled in the art from the following description of a preferred embodiment and the accompanying drawings, in which:.

Aside from the preferred embodiment or embodiments disclosed below, this invention is capable of other embodiments and of being practiced or being carried out in various ways. Thus, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings. If only one embodiment is described herein, the claims hereof are not to be limited to that embodiment. Moreover, the claims hereof are not to be read restrictively unless there is clear and convincing evidence manifesting a certain exclusion, restriction, or disclaimer.

There is shown in <FIG> one embodiment of system <NUM> and the method thereof for cooling the brain of a human subject. System <NUM> includes cooling subsystem <NUM>, shown in greater detail in <FIG>, <FIG>, <FIG>, and <FIG>, configured to input or receive flow <NUM>, <FIG>, of air or breathable gas, cool flow <NUM> of air or breathable gas, and output flow <NUM> of cooled air or breathable gas. In this example, cooling subsystem <NUM> receives flow of air or breathable gas <NUM> from a source of air or breathable gas (e.g., liquid oxygen) located vessel <NUM>, <FIG>, coupled to cooling subsystem <NUM> as shown. In other examples, the source of flow <NUM> of air or breathable gas may be provided by an air or gas compressor which may reduce cost and improve safety when compared using liquid air or air or breathable gas, such as oxygen. In one example, a <NUM>,<NUM> Bar (<NUM>,<NUM> psi), <NUM> (<NUM> gallon) portable air compressor rated <NUM>,<NUM><NUM> (<NUM> cubic feet) per minute at <NUM>,<NUM> Bar (<NUM> psi) may be utilized to provide about supply pressure of flow <NUM> of air or breathable gas at about <NUM> to about <NUM>/min. In other examples, flow <NUM> of air or breathable gas may be the air or breathable gas lines at a hospital or similar type facility. In another example, a small blower or small compressor that provides about <NUM> to about <NUM>/min (LPM) at low Bars (psi) (e.g., less than about <NUM>,<NUM> Bar (<NUM> psi)) may be used within a portable housing, e.g., housing <NUM>, <FIG>, which preferably houses the primary components of system <NUM>.

In one design, cooling subsystem <NUM>, shown in greater detail in <FIG>, receives flow <NUM> of air or breathable gas from the source of air or breathable gas discussed above at input <NUM>, cools flow <NUM> of air or breathable gas, and outputs flow <NUM> of cooled air or breathable gas at outlet <NUM>, as shown. Outlet <NUM>, also shown in <FIG> and <FIG>, is preferably coupled to line or tube <NUM>, <FIG>, which preferably delivers flow <NUM> of cooled air or breathable gas to a device adapted to deliver flow <NUM> of cooled air or breathable gas to human subject <NUM>, e.g., a nasal cannula, as shown, or similar type device, to provide effective cooling of the brain of the human subject <NUM> and provide TH and TTM to normothermic levels at the point of injury or prior to hospitalization early in the therapeutic window, e.g., less than about <NUM> minutes, as discussed in further detail below.

System <NUM> also includes flow control device <NUM>, <FIG>, coupled to cooling subsystem <NUM>. Flow control device <NUM> is configured to control a flow rate of the flow <NUM> of air or breathable gas input to cooling subsystem <NUM> at input <NUM>, <FIG>, and a flow rate of flow <NUM> of cooled air or breathable gas output at <NUM> and coupled to line <NUM>. In one example flow <NUM> of air or breathable gas and flow <NUM> of cooled air or breathable gas are preferably provided by flow control device <NUM> at a flow rate in the range of about <NUM> to about <NUM>/min.

System <NUM>, shown in one or more of <FIG>, also includes one or more flow rate sensors <NUM>, <FIG>, coupled to cooling subsystem <NUM> which are configured to measure at least a flow rate of flow <NUM> of air or breathable gas and flow <NUM> of cooled air or breathable gas.

System <NUM> also includes one or more temperature sensors <NUM> configured to measure at least a temperature of the brain of human subject <NUM>, <FIG>, or the temperature of a brain correlative site of human subject <NUM>, the temperature of flow <NUM>, <FIG> and <FIG>, of air or breathable gas and the temperature of flow <NUM> of cooled air or breathable gas. The temperature of the flow <NUM> of cooled air or breathable gas is preferably measured by one or more temperature sensors <NUM> at point <NUM>, <FIG>, e.g., at output <NUM>, <FIG>, such that the temperature of flow <NUM> of cooled air or breathable gas in line <NUM>, <FIG>, entering the device adapted to deliver flow <NUM> of cooled air or breathable gas to human subject <NUM>, e.g., nasal cannula <NUM> can be controlled, as discussed below. The temperature at the end of nasal cannula <NUM> is also preferably measured by one or more temperature sensors <NUM>, <FIG>, placed at the end of nasal cannula <NUM> and the ternperature of the brain or a brain correlative site of human subject <NUM> is also preferably measured with temperature sensor <NUM>, e.g., using tympanic sensor <NUM>, <FIG>, placed in the ear of human subject, <FIG>, as shown, or a temporal artery sensor, or similarly type temperature sensor, configured to measure the temperature of the brain or a brain correlative site of human subject <NUM>. System <NUM> also includes controller <NUM>, <FIG>, coupled to cooling subsystem <NUM>, flow control device <NUM>, one or more flow rate sensors <NUM>, and one or more temperature sensors <NUM>. Controller <NUM> is configured to adjust a cooling rate, the temperature, and the flow rate of flow <NUM>, <FIG> and <FIG>, of cooled air or breathable gas delivered to human subject <NUM>, <FIG>, based on at least the measured temperature of the brain and the measured flow rate of the flow <NUM> of cooled air or breathable gas to cool the brain of the human subject. System <NUM>, <FIG>, <FIG> and <FIG> also preferably includes user interface/display <NUM>. System <NUM> also preferably includes gas pump <NUM>, <FIG>, coupled to flow control device <NUM> and cooling subsystem <NUM> as discussed above.

In one example, controller <NUM> is preferably configured to automatically adjust the cooling rate, the temperature, and the flow rate of flow <NUM> of cooled air or breathable gas <FIG> and <FIG>, based on feedback information provided the one or more temperature sensors <NUM> configured to measure the temperature of the brain of human subject <NUM> and one or more flow rate sensors <NUM> which measure the flow rate of flow <NUM> of cooled air or breathable gas indicated at <NUM>, <FIG>. In one example, feedback control for controller <NUM> may be from temperature sensors <NUM> configured to measure the temperature of the brain or a brain correlative site, similar to a Proportional, Integral, Derivative (PID), as known by those skilled in the art.

Controller <NUM> is also preferably configured to control flow control device <NUM> to adjust the pressure of flow <NUM> of air or breathable gas <NUM> and flow <NUM> of cooled air or breathable gas. In one example, one or more flow rate sensors <NUM> may be an air flow gage which provides flow rate information about the flow rate of flow <NUM> of cooled air or breathable gas at point <NUM> to controller <NUM> which controls flow control device <NUM> coupled to air or gas pump <NUM> to provide a flow rate of flow <NUM> of air or breathable gas and flow <NUM> of cooled air or breathable gas preferably in the range of about <NUM> to <NUM>/min, as discussed above, or similar type flow rate as needed to cool the brain of human subject <NUM>. Gas pump <NUM> may include a blower preferably configured to sweep flow <NUM> of cooled air or breathable gas, <FIG>, in line or tube <NUM>, <FIG>, rapidly using fans or similar type devices, radially, linearly. In other designs, gas pump <NUM> may include various embodiments of a compressor as discussed above which, in one example provides a supply pressure of flow <NUM> of air or breathable gas at about <NUM> to <NUM>/min. The compressor may include linear, diaphragm, turbine, radial blower or other designs configured to provide an elevated pressure and flow rate of flow <NUM> of air or breathable gas and flow <NUM> of cooled air or breathable gas. In other examples, air or gas pump <NUM> may be a supply line of air or air or breathable gas from a hospital facility or similar type supply line.

System <NUM> also includes and power supply <NUM> coupled to controller <NUM> which preferably provides power to controller <NUM> and power for cooling subsystem <NUM>, one or more temperature sensors <NUM>, flow control device <NUM>, one or more flow rate sensors <NUM> and user interface display <NUM> of system <NUM>. In one example, power supply <NUM> may be a battery, e.g., a nickel metal hydride battery, a lithium ion battery, a lithium polymer, or similar type battery.

As discussed above, the flow rate of flow <NUM> of cooled air or breathable gas, <FIG> provided by cooling subsystem <NUM>, is preferably in the range of about <NUM> to about <NUM>/min. In other examples, the flow rate of flow <NUM> of cooled air or breathable gas, provided by cooling subsystem <NUM> may be greater or less than <NUM>/min. In one example, about <NUM>,<NUM>/min (<NUM> cubic feet per minute (CFM)) of flow <NUM> of cooled air or breathable gas may be provided by cooling subsystem <NUM> and delivered to human subject <NUM> to effectively cool the brain of human subject <NUM>. In one example, cooling subsystem <NUM> is configured to cool flow <NUM> of air or breathable gas at a temperature in the range of about -<NUM> to about <NUM> to provide flow <NUM> of cooled air or breathable gas at a temperature of about - <NUM> to about <NUM>. to effectively and efficiently cool the brain of human subject <NUM>.

The intranasal cooling using forced flow <NUM> of cooled air or breathable gas provided by system <NUM> discussed above provides an effective approach for achieving clinically significant brain cooling to provide TH and TTH at the point of injury, e.g., in pre-hospital settings, such as military far-forward operations, during transportation, in temporary and permanent medical facilities, and the like, early in the therapeutic window, e.g., less than about <NUM> minutes. The nasal cavity is well adapted to cooling the brain because its close proximity to the cavernous sinus and internal carotid artery and cerebrospinal fluid in the basal cistern which circulates through the brain. A tracheal intubated patient loses all cooling circulation through the nasal cavity which results in immediate warming of the brain. System <NUM> and method thereof reverses the warming effects of intubation and dramatically increases normal respiratory cooling effects by forcing a high volume of flow <NUM> of cooled air or breathable gas into the nasal cavity while automatically adjusting the cooling rate based on the temperature of the brain or a brain correlative site, e.g., using one or more temperature sensors <NUM>, such as a tympanic temperature sensor, temporal artery sensor, or similar type sensor discussed above, to achieve rapid brain cooling and controlled hypothermia or normothermia.

The result is system <NUM> and the method thereof provides a less complex and less cumbersome system and method for cooling the brain discussed in the Background section above. System <NUM> and the method there of provides a forced flow of cooled air or breathable gas that efficiently cools the brain to effectively provide TH and TTM to normothermic levels at the point of injury or prior to hospitalization and early in the therapeutic window, monitors the temperature of the brain and human subject, and adjusts temperature and flow rate of the flow of cooled air or breathable gas to reduce possible adverse side effects which may be associated with cooling the brain of a human subject.

Controller <NUM> shown in one or more of <FIG> and <FIG> may be a processor, one or more processors, an application-specific integrated circuit (ASIC), firmware, hardware, and/or software (including firmware, resident software, micro-code, and the like) or a combination of both hardware and software that may all generally be referred to herein as a "controller", which may be part of system <NUM> and method for cooling the brain of this invention. Computer program code for the programs for carrying out the instructions or operation of one or more embodiments of the system <NUM> and method and controller <NUM> may be written in any combination of one or more programming languages, including an object oriented programming language, e.g., C++, Smalltalk, Java, and the like, or conventional procedural programming languages, such as the "C" programming language or similar programming languages.

In one example, cooling subsystem <NUM>, shown in one or more of <FIG>, preferably includes gas block <NUM>, <FIG>, coupled to input <NUM> and output <NUM>, e.g., as shown in <FIG>. Gas block <NUM>, <FIG>, preferably includes flow channels <NUM> which direct flow <NUM> of air or breathable gas <NUM>, <FIG> and <FIG>, received at input <NUM>, <FIG>, through gas block <NUM>, <FIG>, where flow <NUM> of air or breathable gas <NUM> is cooled to create flow <NUM> of cooled air or breathable gas. Flow channels <NUM> direct flow <NUM> of cooled air or breathable gas to output <NUM>, e.g., as shown in <FIG>. Preferably, flow channels <NUM> are tight thermally conductive channels made of aluminum, copper, brass, steel, or similar type materials. Gas block <NUM> also includes cover <NUM>. Cooling subsystem <NUM> may also include gas filter <NUM>, <FIG> and <FIG>, which is preferably coupled to gas block <NUM>.

In one design, cooling subsystem <NUM> also preferably includes heat transfer subsystem <NUM>, <FIG>, configured to efficiently and effectively cool flow <NUM> of air or breathable gas <NUM>, <FIG>, to provide flow <NUM> of cooled air or breathable gas. In one design, heat transfer subsystem <NUM> is configured as thermoelectric cooler (TEC) <NUM>, <FIG>, which is preferably based on the Peltier effect, to transfer heat from cold side <NUM> of TEC <NUM> to flow <NUM> of air or breathable gas <NUM> inside gas block <NUM> to effectively cool flow <NUM> of air or breathable gas <NUM> to provide flow <NUM> of cooled air or breathable gas at outlet <NUM>, e.g., as shown in <FIG> and <FIG>. Thus, TEC device <NUM> preferably provides a temperature differential needed to effectively remove heat from flow <NUM> of air or breathable gas <NUM>. In one example, TEC device <NUM> may be a commercially available TEC (available from TE Technology, Traverse City, MI) and is preferably rated to remove tip to about <NUM> W of heat at <NUM> W of power or more. In other designs, heat transfer subsystem <NUM>, <FIG>, may utilize a refrigerant or heat transfer by radiation to transfer cold gas/liquid flow to cool flow <NUM> of air or breathable gas <NUM> in gas block <NUM>. The primary function heat transfer subsystem <NUM> is to remove heat from flow <NUM> of air or breathable gas <NUM> received at input <NUM> and provide flow <NUM> of cooled air or breathable gas at outlet <NUM>, as shown in <FIG> and <FIG>, which is delivered to human subject <NUM>, e.g., by nasal cannula <NUM>, <FIG>, coupled to line <NUM> to effectively and efficiently cool the brain of human subject <NUM>. The heat removed from flow <NUM> of air or breathable gas <NUM> may be removed during flow or removed while in reserve mode,.

Cooling subsystem <NUM> shown in one or more of <FIG> also preferably includes heat exchanger subsystem <NUM>, <FIG>, coupled to heat transfer subsystem <NUM>, e. g, TEC <NUM>. Heat exchanger subsystem <NUM> is preferably configured to remove heat from hot side <NUM> of TEC <NUM> and expel warn exhaust air or air or breathable gas <NUM>, <FIG> and <FIG>, into the atmosphere as shown.

In another example, TEC <NUM> may be utilized as a heating subsystem to heat flow <NUM> of air or breathable gas <NUM> and/or flow <NUM> of cooled air or breathable gas when the temperature thereof is too high. In one example, because TEC <NUM> is a bipolar device, if the temperature of flow <NUM> of air or breathable gas <NUM>, <FIG> and <FIG>, or flow <NUM> of cooled air or breathable gas is colder than desired, e.g., as set by controller <NUM>, <FIG>, and measured by one or more temperature sensors <NUM>, TEC <NUM> can be configured and controlled by controller <NUM> to control the current or the voltage applied to TEC <NUM> such that cold side <NUM>, <FIG>, will become a hot side and heat flow <NUM> of air or breathable gas <NUM> inside gas block <NUM> to increase the temperature of flow <NUM> of cooled air or breathable gas to provide the desired temperature of flow <NUM> of cooled air or breathable gas delivered via line <NUM>, <FIG>, to the device adapted to deliver flow <NUM> of cooled air or breathable gas to human subject <NUM>, <FIG>, e.g., a nasal canular or similar type device.

In one design, heat exchanger subsystem <NUM>, <FIG>, preferably includes heat conductor block <NUM> coupled to hot side <NUM> of TEC <NUM> and to conductive heat pipes <NUM> surrounded by conductive fins <NUM>. Heat exchanger fan <NUM> is preferably coupled to conductive fins <NUM>, e.g. as shown in <FIG>. Heat conductor block <NUM> is preferably configured to efficiently remove heat from hot side <NUM> of TEC <NUM>. The heat from conductor block <NUM> is preferably transferred to conductive pipes <NUM> and cooled by conductive fins <NUM>. Heat exchanger fan <NUM> removes the heat in conductive fins <NUM>. In one design, heat conductor block <NUM>, heat conductive pipes <NUM> and conductive fins <NUM> are made of a highly thermally conductive material, e.g., aluminum, copper, brass, steel, and the like. In another design, the warm air removed using the heat exchanger fan <NUM> or other flow over hot side <NUM> of the TEC <NUM> can be used to warm the human subject <NUM>,.

In one design, system <NUM> and the method thereof, shown in one or more of <FIG>, may include humidifier <NUM>, <FIG>, which preferably supplies moist air to line or tube <NUM>, <FIG>, coupled to nasal cannula <NUM>. In one design, a drip base system within line <NUM> may be utilized where intimate drops of liquid are provided into line <NUM> and swept with flow <NUM> of cooled air or breathable gas. In other examples, passing flow <NUM> of cooled air or breathable gas over a source of liquid may be utilized where flow <NUM> of cooled air or breathable gas is brought into contact with a liquid and not passed through it. In other examples, an in-line humidifier may be utilized.

In one design, user interface/display <NUM>, <FIG>, <FIG> and <FIG> may provide a user interface for users of system <NUM> to provide input parameters to determine the various control options of system <NUM> and the method thereof discussed above. In one design, an LED or LCD screen may be utilized for a display that may be touch sensitive or use tactile visual and/or audio feedback buttons and preferably includes indicator light emitting devices or audible devices, such as buzzers or speakers,.

One example of the method for cooling the brain of a human subject includes receiving a flow of the air or breathable gas, step <NUM>, <FIG>. The air or breathable gas is cooled, step <NUM>. A flow of cooled air or breathable gas is output to a line coupled to a device adapted to deliver the cooled air or breathable gas to a human subject, step <NUM>, A flow rate of the flow of the air or breathable gas and a flow rate of the cooled air or breathable gas output to the line is controlled, step <NUM>. At least a flow rate of flow of cooled air or breathable gas is measured, step <NUM>. At least a temperature of a brain or a brain correlative site of the human subject and a temperature of the flow of cooled air or breathable gas is measured, step <NUM>, A cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas delivered to the human subject is adjusted based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas to cool the brain of the human subject, step <NUM>. The words "including", "comprising", "having", and "with" as used herein are to be interpreted broadly and comprehensively and are not limited to any physical interconnection. Moreover, any embodiments disclosed in the subject application are not to be taken as the only possible embodiments.

Claim 1:
A system (<NUM>) for cooling the brain of a human subject, the system (<NUM>) comprising:
a cooling subsystem (<NUM>) configured to input a flow of air or breathable gas (<NUM>), cool the air or breathable gas, and output a flow of cooled air or breathable gas (<NUM>) to a line (<NUM>) coupled to a device (<NUM>) adapted to deliver the flow of cooled air or breathable gas to a human subject (<NUM>), the cooling subsystem (<NUM>) including a flat gas block (<NUM>) comprised of a thermally conductive material and a flat thermoelectric cooler (TEC) (<NUM>) coupled to the flat gas block (<NUM>), the flat gas block (<NUM>) including an inlet (<NUM>) configured to input the flow of air or breathable gas (<NUM>) and an outlet (<NUM>) configured to output the flow of cooled air or breathable gas (<NUM>);
a flow control device (<NUM>) coupled to the cooling subsystem (<NUM>) configured to control a flow rate of the flow of the air or breathable gas input (<NUM>) to the cooling subsystem (<NUM>) and a flow rate of the flow of cooled air or breathable gas (<NUM>) output to the line (<NUM>);
one or more flow rate sensors (<NUM>) coupled to the cooling subsystem (<NUM>) configured to measure at least a flow rate of flow of cooled air or breathable gas (<NUM>);
one or more temperature sensors (<NUM>) configured to measure at least a temperature of a brain or a brain correlative site of the human subject (<NUM>) and the temperature of the flow of cooled air or breathable gas (<NUM>); and
a controller (<NUM>) coupled to the cooling subsystem (<NUM>), the flow control device (<NUM>), the one or more flow rate sensors (<NUM>), and the one or more temperature sensors (<NUM>), the controller (<NUM>) configured to adjust a cooling rate, the temperature, and the flow rate of flow of cooled air or breathable gas (<NUM>) delivered to the human subject (<NUM>) based on at least the measured temperature of the brain or the brain correlative site and the measured flow rate of the flow of cooled air or breathable gas (<NUM>) to cool the brain of the human subject (<NUM>).