the present invention is a cooling - normothermic - heating device 10 . the device 10 has a housing 12 defining a negative pressure chamber 14 , a heat - exchange element 16 and a seal 18 . housing 12 may be made from a cover 22 and a base 24 . the housing 12 could be of numerous shapes designed to enclose a portion of a patient &# 39 ; s body . the portion that contacts the heat exchange element 16 is referred to as a target heat exchange surface . the portion of the patient &# 39 ; s body can be a foot , leg , feet , legs , arm ( s ), hand ( s ) or combinations thereof . housing 12 may be constructed from multiple pieces , including an end cap 26 as shown , or it may be provided as a unitary structure . cap 26 is shown having ports 28 . a first port may be utilized for connection to a vacuum source , while the second may be utilized for a vacuum gauge . of course , alternate port placement is also possible . negative pressure chamber 14 is preferably provided between heat exchange element 16 and cover 22 as shown in fig1 , or surrounded by housing 12 with the heat exchange element 16 in and / or near the middle of the housing as shown in fig4 . the negative pressure generated in the negative pressure chamber 14 is the result from any device 140 ( vacuum like generator ) that can create the desired negative pressure in the chamber 14 . the device 140 can be independent from the housing 12 as illustrated in fig1 or a part of the housing 12 as illustrated in fig4 . in any case , the device 140 is electrically interconnected with a biofeedback sensor 150 when the device 10 is being used with a patient . the biofeedback sensor 150 contacts at least a portion of the patient when the device is used in association with the patient . heat exchange element 16 is preferably made of a thermally conductive material , like and not limited to aluminum . it may be in communication with a peltier device , a desiccant cooling device , an endothermic chemical reaction , or an exothermic chemical reaction to provide a desired temperature to the target surface area . these chemicals and / or devices can be positioned in a cavity 36 between the element 16 and the base 24 as illustrated in fig1 ( or within the element 16 for the embodiment illustrated in fig4 ), and be inserted into and / or electrically connected through an inlet / outlet ( s ) 34 as illustrated in fig2 , 3 , and 4 . more preferably heat exchange member 16 is in communication with at the inlet and the outlet 34 to accommodate a flow of perfusion fluid ( liquid and / or gas ) behind ( as illustrated in fig1 - 3 ) the heat exchange surface 32 or within ( as illustrated in fig4 ) element 16 . chilled or heated water may be used to maintain the contact surface of the element at a desired temperature . optimally , perfusion fluid is run through a series of switchbacks in the cavity 36 , or within the element 16 . the device 10 uses a conventional soft or hard seal 18 to enclose at least the target heat exchange surface in the negative pressure chamber 14 . the seal 18 could be polymeric material , webbing as illustrated in fig1 , 2 and 3 with seal supports 20 , or a conventional mechanical iris - like design that opens and closes as illustrated in fig4 . in any seal embodiment , the seal 18 must have an aperture 19 to allow the patient &# 39 ; s body part enter into the negative pressure chamber 14 . the device 10 also has the biofeedback sensor 150 that measures and / or detects a biofeedback parameter and transmits a sensor signal 152 regarding the measurement and / or detected biofeedback parameter directly to or indirectly to the negative pressure generator 140 that provides , controls and / or manages the negative pressure within the negative pressure chamber 14 in response to the sensor &# 39 ; s signal . various methods and devices may be used for determining a characteristic associated with vasoconstriction or vasodilation in a body portion . in one exemplary method for determining whether a body portion is in a vasoconstriction or vasodilation state , the body portion is monitored by measuring blood flow in the particular body portion . normally , when body and / or environmental temperatures are high , the dilation of certain blood vessels favors high blood flow to these surfaces , and as environmental and / or body temperatures fall , vasoconstriction reduces blood flow to these surfaces and minimizes heat loss to the environment . as such , measuring the blood flow rate in a body portion provides a measure of whether the body portion is in a state of vasoconstriction or vasodilation . in another exemplary method for measuring vasoconstriction or vasodilation , blood flow in the body portion is measured and monitored by laser doppler blood flowmetry . laser doppler measurement of the blood flow in a body portion provides a measure of whether the body portion is in a state of vasoconstriction or vasodilation , since changes in blood flow rate are measured . in one example , a laser doppler imager integrated into a heat exchange device and directed toward the palm , a finger , or other body portion is used to measure changes in blood flow rate through the body portion . alternatively , vasoconstriction or vasodilation may be monitored by measuring the volume of a body portion . it is commonly understood that vasodilation coincides with a greater body portion volume than observed during vasoconstriction owing to increased blood volume within the body portion during vasodilation . as such , a physical change in the volume of a body portion can be correlated to a condition of vasodilation or vasoconstriction . one example of measuring the volume of a body portion would be to immerse the body portion in a fluid medium . any changes in the body portion volume would be registered by a change in the volume of fluid medium displaced by the body portion . or , it may be measured by an impedance - type sensor . alternatively , vasoconstriction or vasodilation may be monitored by measuring the heat transfer of a body portion . for example , the heat transfer of a body portion is tested by measuring the presence or absence of a temperature gradient when measuring the temperature difference , e . g ., between a finger and the corresponding forearm of an arm . the absence of a temperature gradient ( indicative of heat transfer to the finger ) correlates with a condition of vasodilation in the finger , while a higher temperature in the forearm than in the finger ( indicative of no heat transfer to the finger ) correlates with a condition of vasoconstriction . alternatively , vasoconstriction or vasodilation may be monitored by measuring the heat flux at the skin surface . for example , the heat flux at the skin surface is tested by placing a temperature sensing device between the skin surface and a cooling object in contact with the skin &# 39 ; s surface . the temperature at this sensing device will indicate vasoconstriction or vasodilation . a temperature higher than that of the cooling object will indicate vasodilation while a temperature close to that of the cooling object will indicate vasoconstriction because the skin surface will be cooler . alternatively , vasoconstriction or vasodilation is monitored by measuring light absorption of a portion of the body . for example , light absorption can be detected using the technique of plethysmography or through use of an infrared pulse oximeter . alternatively , vasoconstriction or vasodilation may be monitored by measuring the temperature of the body of a mammal . any convenient temperature sensing means may be employed , where suitable means include but are not limited to : thermometers , thermocouples , thermoresistors , microwave temperature sensors , and the like . the position and nature of the temperature sensing devices generally depends on the body portion being tested . temperature measurement may involve monitoring the core body temperature of a mammal . by core body is meant the internal body region or portion of the mammal , as opposed to the surface of the mammal . specific core body regions of interest are the core body region of the head , e . g ., the deep brain region , and the core body region of the trunk of the mammal , e . g ., the thoracic / abdominal region of the mammal . for detecting the core body region temperature of the head , sensor locations of interest include : the auditory canal ( tympanic ), the oral cavity , and in the case of microwave detection , anywhere on the surface of the head to measure underlying temperature . for detecting thoracic / abdominal core body temperature , sensor locations include : the esophagus , the rectum , the bladder , the vagina , and in the case of microwave detection , anywhere on the surface of the body to measure the underlying temperature . alternatively , vasoconstriction or vasodilation may be monitored by measuring the skin temperature of a mammal . for detecting the skin temperature of a mammal , the simple empirical nursing methodology of holding the hand to test for warmth or coldness can be used . in practicing this method of skin temperature measurement , a warm hand is generally associated with vasodilation , while a cold hand is associated with vasoconstriction . the temperature of the skin can also be detected using sensors such as thermocouples , thermometers , thermoresistors , microwave temperature sensors , temperature sensitive liquid crystals , and other temperature measuring devices . placement of temperature sensors on the skin surface could be at the site of heat transfer or other locations , or a combination of locations . in one example , vasoconstriction or vasodilation may be monitored by measuring changes in skin surface temperature or heat flow from the body across local skin surface area overlying heat exchange vascular structures . as for these means of monitoring vasoconstriction or vasodilation through temperature observation , note — that only detecting temperature at the location of heat transfer provides a direct measure of local vasoconstriction . however the monitoring is effected ( even — for example — by a combination of any two or more of the above approaches ), by controlling vasoconstriction or vasodilation in a body portion of a mammal , the vasoconstriction temperature and the heat transfer temperature can be lowered to increase the temperature gradient between the area of the body containing heat exchange vasculature and the environment , thus increasing heat transfer and facilitating core body cooling . the sensor generates a sensor signal 152 in response to the measurement of the patient . the sensor signal 152 is transmitted to a comparator 220 or equivalent device . the comparator 220 can be positioned in the device 10 as illustrated in fig4 or outside the device 10 as illustrated in fig1 . the comparator 220 determines if the target surface area is experiencing vasodilation . if the surface area is not experiencing vasodilation , the comparator transmits an on - signal for the negative pressure generator 140 to at least throttle the desired negative pressure in the negative pressure chamber 104 to vasodilate the target surface area . applying a negative pressure condition to a portion of the body can lower the vasoconstriction temperature and / or increase vasodilation in the body portion . in practicing the exemplary methods , the negative pressure conditions may be provided using any convenient protocol . in many embodiments , the negative pressure conditions are provided by enclosing a body portion of the mammal in the negative pressure chamber 14 , where the pressure is then reduced in the sealed enclosure thereby providing the desired negative pressure that includes a target heat exchange surface . in many examples of the present methods and systems , the portion that is sealed includes an arm or leg , or at least a portion thereof , e . g ., a hand or foot . the nature of the enclosure will vary depending on the nature of the appendage to be enclosed , where representative enclosures include gloves , shoes / boots , or sleeves . negative pressure includes conditions where a pressure lower than ambient pressure under the particular conditions in which the method is applied , e . g ., 1 atm at sea level . the magnitude of the decrease in pressure from the ambient pressure under the negative pressure conditions in one example is at least about 20 mmhg , preferably at least 30 mmhg , and more preferably at least about 35 mmhg , where the magnitude of the decrease may be as great as 85 mmhg or greater , but preferably does not exceed about 60 mmhg , and more preferably does not exceed about 50 mmhg . when the method is performed at or about sea level , the pressure under the negative pressure conditions generally may range from about 740 to 675 mmhg , preferably from about 730 to 700 mmhg and more preferably from about 725 to 710 mmhg . in practicing the exemplary methods , the negative pressure conditions during contact with the skin of a subject may be static / constant or variable and no matter what is turned on in response to the sensor signal . thus , in certain examples , the negative pressure is maintained at a constant value during contact of the surface with the low temperature medium to obtain the desired vasodilation . in yet other examples , the negative pressure value is varied during contact , e . g ., oscillated . where the negative pressure is varied or oscillated , the magnitude of the pressure change during a given period may be varied in response to the sensor signal and may range from about 85 to 40 mmhg , and preferably from about 40 to 0 mmhg , with the periodicity of the oscillation ranging from about 0 . 25 sec to 10 min , and preferably from about 1 sec to 10 sec . the device 10 may also have a systems controller 400 that provides and receives signals from the various system components to achieve controlled thermal energy transfer from at least a portion of the patient and / or control the vasodilation through the negative pressure applied to the target surface area . the systems controller 400 may include a unit having a suitably programmed microprocessor or the like , including algorithms or program logic for various heating , normothermic , and cooling protocols and schedules as desired . the algorithms may be carried out through software , hardware , firmware , or any combination thereof . the programming can be recorded on computer readable media , ( e . g ., any medium that can be read and accessed directly by a computer ). such media include , but are not limited to : magnetic storage media , such as floppy discs , hard disc storage medium , and magnetic tape ; optical storage media such as cd - rom ; electrical storage media such as ram , rom , or an eprom ; and hybrids of these categories such as magnetic / optical storage media . any such medium ( or other medium ) programmed ( in full or in part ) to operate according to the subject methodology also forms an aspect of the invention . in some embodiments , the systems controller 400 is in communication with the vacuum generator 140 and the thermal exchange engine 180 which is capable of heating or cooling a heat exchange medium ( not shown ) in communication with the within the cavity 36 . the heat exchange medium provided may communicate thermally with at least a portion of the mammal and with at least a portion of the conductor 32 . in certain examples , the heat exchange medium is comprised of a fluid such as water , oil , and the like . in other examples the heat exchange medium may include gas or air . in further examples , the heat exchange medium may include solid - state heating or direct electrical heating . additionally , the systems controller is in communication with a reservoir ( not shown ) for containing a supply of heat exchange medium . though the invention has been described in reference to several examples , optionally incorporating various features , the invention is not to be limited to that which is described or indicated as contemplated with respect to each embodiment or variation of the invention . it will be apparent to those skilled in the art that numerous modification and variations within the scope of the present invention are possible . thus , the breadth of the present invention is to be limited only by the literal or equitable scope of the following claims — not the description provided herein .
the present invention is directed to using a thermoregulatory sensor in conjunction with a cooling - normothermic - heating device that applies a desired thermal energy to a target heat exchange surface of a mammal that is under negative pressure . the thermoregulatory sensor , unlike the prior art , does not initiate and / or control the thermal energy applied to the mammal . instead the thermoregulatory sensor initiates , controls and / or manages the negative pressure applied to the target heat exchange surface . by initiating , controlling and / or managing the negative pressure , the vasodilation of the target heat exchange surface is also controlled and / or managed and / or thermal communion between the exchange surfaces is controlled , and / or managed .