Abstract:
A device and method for non-invasive treatment of menopausal hot flashes. The device includes a hand-held assembly sized to be held in the palm of a user&#39;s hand; a cooling plate within the assembly and a cradle which docks with the assembly. The cradle plugs into an AC power source and includes a Peltier-effect element for cooling a contact plate. The contact plate in the cradle abuts the cooling plate in the docked assembly and cools the same, keeping it at the lowered temperature and ready for immediate use. The cradle includes a heat sink for dissipating heat generated by the Peltier-effect element. The assembly is undocked from the cradle. The cooled plate is placed against the skin on the back of the neck and is moved back and forth to stimulate cold thermoreceptors in the skin, thereby counteracting the false trigger which caused the hot flash.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Technical Field 
         [0002]    This invention generally relates to therapeutic devices. More particularly, the invention relates to a device that is useful for controlling or stopping a menopausal hot flash. Specifically, the device includes at least one plate that is cooled using a Peltier-effect element and the cooled plate is moved back and forth across the skin on the back of the neck to stimulate cold thermoreceptors in the skin and thereby counteract the false triggering of the hypothalamus which causes a hot flash. 
         [0003]    2. Background Information 
         [0004]    Mammals are warm blooded creatures that are able to thrive in a wide range of environments for a number of reasons. One of these reasons is that that their bodies are provided with complex thermoregulatory systems that enable them to monitor the ambient temperature, i.e., the temperature of their surroundings, and to adjust various bodily functions to keep their internal core temperature substantially constant. The core temperature is vital to the survival of the mammal in that if it becomes too high they will die and if it drops too low they will die. If the ambient temperature increases, the mammal&#39;s body will tend to absorb some of this surrounding heat and their core temperature will tend to rise in response. Similarly, if the ambient temperature drops, the body will naturally radiate heat into the environment thereby causing a drop in the body&#39;s core temperature. The thermoregulatory system will adjust body functions so as to lose heat, prevent heat loss or even generate heat in order to keep the core temperature more or less constant. 
         [0005]    In humans, who are mammals, one of the most important parts of this thermal monitoring and regulation system is the skin. Skin includes both hot and cold temperature receptors (thermoreceptors) that detect the ambient temperature and then fire a signal to the hypothalamus. The hypothalamus takes action in response to this data and changes various bodily functions to regulate the core temperature. These bodily functions controlled by the hypothalamus include, but are not limited to, the body&#39;s heart rate, the rate of breathing, the extent of blood flow to the extremities, and rates of sweating and shivering. If, for example, the thermoreceptors in the skin indicate that the environment is too hot and that the core temperature is therefore likely to rise, the heart rate will be increased and blood flow to the capillaries that are just beneath the skin&#39;s surface will be increased. Both of these actions bring warmed blood closer to the skin very rapidly so that heat can radiate from the blood to the environment. Additionally, the sweat glands are stimulated and liquid is released onto the skin&#39;s surface. Evaporation of this liquid utilizing heat from the blood close to the skin&#39;s surface causes the temperature of the skin, the blood and therefore the body&#39;s core to be lowered. If, on the other hand, the receptors detect that the environment is too cold and that the core temperature is therefore in jeopardy of falling too low, the thermoregulatory system will slow the heart rate and will decrease blood flow to the body&#39;s extremities which causes capillaries close to the skin&#39;s surface to close. This slows down the rate at which heat is radiated into the environment from the body. Furthermore, hair follicles on the skin&#39;s surface are stimulated to vibrate, a condition typically referred to as shivering. This generates heat which flows into the blood. These actions help to keep the body&#39;s core temperature in a safe range. 
         [0006]    As any menopausal woman knows, one of the most unpleasant symptoms of this time of life is the disruption in the body&#39;s complex thermoregulatory system. There is periodically a false triggering of the thermoregulatory system which affects or is internal to the hypothalamus. This false trigger causes the hypothalamus to determine that the body&#39;s core temperature is rising rapidly and is getting dangerously high. The hypothalamus responds by taking the action that is typically required to lower the core temperature. This response includes vascular dilation and an increase in heart rate to get blood more rapidly to the skin for cooling. These actions cause the woman to feel flushed, out of breath and extremely hot as the blood is rushed to the skin. In other words, the woman has a hot flash. The result of this hypothalamic action is that the body&#39;s core temperature drops by as much as two to three degrees Celsius. Once the hot flash is over, the woman may experience chills for an hour or more as her body attempts to build back up to a safer core temperature range. While hot flashes cause the body temperature to rise rapidly for one or two minutes and are then gone, these extreme temperature swings can leave the woman drained and emotionally distraught. While this condition is hormonally cradled and is therefore extremely difficult to avoid or correct, it is desirable that at least the symptoms thereof be addressed in some manner that will bring the menopausal woman relief and leave her with a greater sense of being in control of her own body. 
         [0007]    The present inventor has recognized that the body&#39;s own thermoregulatory system may be utilized to aid in reducing the menopausal symptoms known as hot flashes. Furthermore, the inventor has recognized that the skin plays a large role in assisting to keep the core temperature of the body more or less constant. Even further, the inventor has recognized that the skin at the back of the neck has a very high density of thermoreceptors and that it is a key area of the body that the hypothalamus monitors in determining ambient temperature. 
         [0008]    The prior art has disclosed various devices and modalities for the treatment of other ailments that utilize neural pathways and for cooling the body. One such device and modality is disclosed in U.S. Pat. No. 5,632,769 to Saringer. Saringer&#39;s device is used in the treatment of intense localized pain and includes a mechanism for creating a spatial temperature differential in one of the device&#39;s surfaces. The temperature differential is set up in a surface area that is around 1 square centimeter in size, and the mechanism generates an intensely high temperature in a first region of this surface and an intensely low temperature in a second region of this surface. The high temperature is maintained at around 45 degrees Centigrade and the low temperature is maintained at around 0 degrees Centigrade. The temperature differential is therefore around 45 degrees Centigrade across this 1 square centimeter. This small surface area is then placed in contact with the user&#39;s skin in the immediate area experiencing pain and is kept in place for a period of 15 to 24 minutes. The sensation generated by the device is felt by the user as intense heat. The temperature differential generates a large neural signal that travels along much the same neural pathways as the pain signals would travel, and the pain signals are effectively blocked by this device. 
         [0009]    U.S. Pat. No. 6,165,640 (Taylor et al) discloses a device for cooling or heating the body. The device is C-shaped and configured to fit around a region of the body to be heated or cooled. In particular, the C-shaped housing encircles at least 220° of the region of the body the device engages. The patent specifically discloses fitting the device around a user&#39;s head or neck. The device includes a first portion that is thicker and contains many of the functional components. Two thinner wings extend outwardly from the thicker region. It is disclosed that when the device is worn around the neck the thicker region is seated adjacent the back of the neck and then the two wings extend forwardly around the neck and toward the front thereof. The device includes a Peltier-effect element for thermal regulation, air intake and exhaust ports, and a thermally conductive heat sink region that is urged into contact with the patient&#39;s skin. The heat sink region extends along substantially the entire interior surface of the C-shaped device so that it is in contact with a substantial area of the user&#39;s skin on the back and sides of the neck. This device may be suitable for continuously cooling the user&#39;s skin and blood but would be ineffective as a menopausal hot-flash treatment device because of the constant contact with the user&#39;s skin. Maintaining constant contact with the skin will cause the thermoreceptors in the user&#39;s neck to stop firing after just a few seconds and thus any benefit derived from the device for stopping a hot flash will be at best extremely short-lived. 
         [0010]    U.S. Pat. No. 6,229,367 (Strauss et al) is also a C-shaped member that is used to cool a region of the user&#39;s body and is specifically indicated as being positionable around the neck. The device includes a heat dissipating member which abuts the region of the user&#39;s body, a liquid-retaining material that contacts the heat dissipating member and a plenum disposed between the heat dissipating member and the liquid-retaining material. The device also includes air intake and exhaust ports and a battery-powered fan to move air through the ports and plenum. Again, the heat dissipating member remains in contact with the skin at all times and so its possible effectiveness for killing hot flashes is, at best, short lived. 
         [0011]    US publication number 2407/0098769 (Champion) discloses a device for treating menopausal hot flashes. The device comprises a cooling device which is adhesively applied on the body of a woman experiencing a hot flash when the first symptoms of a hot flash are detected. The device is placed at a hot flash origin site as determined by the user. Two or more of these cooling devices may be placed at different sites on the body. The devices are wrapped in a sealed package which is broken open when the first symptom of a hot flash is experienced and the device is then adhered to the hot flash origin site. The device may be stored in a refrigerator or a freezer in certain instances so that it is ready to use, or the device may be manufactured from materials that produces causes evaporation from the skin (and therefore cooling), or it may cause an endothermic reaction. According to the publication, the device is placed on the skin for anywhere from about 5 minutes to about 34 minutes. An example device includes more than one cooling region so that when it is adhered to the user&#39;s skin; more than one region of the skin will be cooled. Like the previous devices, because of the constant contact of the cooling regions with the skin, the thermoreceptors in the skin will stop firing within a few seconds and thus the benefits of stopping the hot flash before it is fully developed are lost in this device. 
         [0012]    The present inventor is also named as an inventor in US publication 2410/0225307 (now abandoned) for a hand-held device for treating menopausal hot flashes. The entire specification of this publication is incorporated herein by reference. The device includes Peltier-effect elements for cooling and is placed in abutting contact with the skin on the back of the neck. The location of the device on the skin is changed every ten to fifteen seconds to ensure the thermoreceptors in the skin keep firing and thereby aid in stopping the hot flash. One of the issues with this device is that it takes too long to cycle up, sometimes around 24 to 34 seconds. When sensing the onset of a hot flash if a user can get something very cold onto the back of the neck quickly, then the hot flash may be reversed almost completely. However, if the hot flash becomes too fully developed then while the cold will provide some measure of comfort, the hot flash itself cannot be reversed. The user then just has to ride the rest of the hot flash out. The time that the device described in the publication takes to cycle up is too long to become cold enough to stop a hot flash. It therefore simply becomes a comfort aid when applied to the skin. 
         [0013]    There is therefore a continued need in the art for a method of aiding in the control of the menopausal symptom commonly known as a hot flash and for a device that is used for this purpose. 
       SUMMARY 
       [0014]    A device and method for non-invasive treatment of menopausal hot flashes. The device includes a hand-held assembly sized to be held in the palm of a user&#39;s hand; a cooling plate within the assembly and a cradle which docks with the assembly. The cradle plugs into an AC power source and includes a solid state cooling system, preferably a Peltier-effect element, for cooling a contact plate. The contact plate in the cradle abuts the cooling plate in the docked assembly and cools the same, keeping it at the lowered temperature and ready for immediate use. The cradle includes a heat sink for dissipating heat generated by the Peltier-effect element. 
         [0015]    At the onset of hot flash symptoms the assembly is undocked from the cradle. The cooled plate is placed against the skin on the back of the neck and is move thereacross. Inasmuch as during a hot flash the hypothalamus has been falsely triggered into determining that the body&#39;s core temperature is rising, the device is designed to specifically counteract that false trigger. This is accomplished by the device being used to cool and thereby stimulate the cold thermoreceptors in the skin at the back of the neck. In response to being cooled, the thermoreceptors fire and emit a signal to the hypothalamus indicating that the ambient temperature is extremely cold. In response to this signal, the hypothalamus stops trying to decrease the core temperature of the body. Consequently, the woman&#39;s heart rate slows and blood is no longer rushed to the surface of the skin for cooling. Thus, the false trigger is counteracted and the hot flash effectively ceases. The cooled pad is kept in any one position on the skin for no longer than 10 to 15 seconds as this is the time it typically takes for the thermoreceptors to become saturated and stop emitting a signal to the brain. Since a hot flash typically lasts only for two to three minutes, the cold thermoreceptors need only be stimulated for a very short time in order to cause the hot flash to cease. Furthermore, since the hot flash cycle is interrupted, the body&#39;s core temperature does not drop and there is therefore no need for the body to try and raise the core temperature once again. Consequently, the subsequent adverse effects of the hot flash are also averted by using the device. 
         [0016]    When the hot flash has been stopped using the device, the hand-held assembly is returned to the cradle where the contact plate rapidly cools it down once more. Because the cradle is substantially permanently connected to a remote power source, the contact plate is always in a cooled state and is therefore consistently available to rapidly lower the temperature of the plate in the assembly. The hand-held assembly is thus always ready for immediate use and the configuration of the device is such that the assembly is able to retain the cold for around one half hour before needing to be recharged by docking it with the cradle. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    The device is set forth in the following description and is shown in the drawings and is particularly and distinctly pointed out and set forth in the appended claims. 
           [0018]      FIG. 1  is a top perspective view of the device showing a first side of the hand-held assembly docked in the cradle; 
           [0019]      FIG. 2  is a top perspective view of the device showing a second side of the hand-held assembly docked in the cradle; 
           [0020]      FIG. 3  is an elevational view showing a first end of the device where the hand-held assembly is docked in the cradle; 
           [0021]      FIG. 4  is a first side elevational view of the device in the docked position; 
           [0022]      FIG. 5  is a second side elevational view of the device in the docked position; 
           [0023]      FIG. 6  is a top view of the device; 
           [0024]      FIG. 7  is a cross-sectional view of the device taken along line  7 - 7  of  FIG. 6 ; 
           [0025]      FIG. 8  is a bottom view of the device; 
           [0026]      FIG. 9  is an exploded view of the device showing the component parts of the hand-held assembly and the cradle; and 
           [0027]      FIG. 10  is an end elevational view of the device similar to  FIG. 3  but showing the hand-held assembly undocked from the cradle. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    Referring to  FIGS. 1-10  there is shown a device for aiding in controlling menopausal hot flashes generally indicated at  10 . Device  10  comprises a hand-held assembly  12  and a cradle  14 . Assembly  12  is docked with cradle  14  when not in use and is removed from cradle  14  when it is to be used to treat a hot flash. Assembly  12  includes a cooling pad  16  which engages a cooling system  18  ( FIGS. 7 &amp; 8 ) in cradle  14  when assembly  12  is docked in cradle  14 . Cradle  14  is configured to be connected to a remote power source, such as a supply of alternating current (AC), which keeps the cooling system  18  powered up and ready to rapidly cool down the cooling pad  16 . Thus, when assembly  12  is docked with cradle  14 , the cooling pad  16  is maintained in a substantially constant cooled condition and is therefore always ready for use. 
         [0029]    Referring particularly to  FIG. 9 , hand-held assembly  12  comprises a top cover  20 , a first insulation layer  22 , cooling pad  16 , and a retainer  24 . Cradle  14  includes a bottom cover  26 , a second insulation layer  28 , a housing  30 , an AC-DC adapter  32 , and a solid-state cooling system  18 . Cooling system  18  includes a contact pad  34 , one or more Peltier-effect elements  36 , and a heat sink  38 . All of these components will now be described in greater detail. 
         [0030]    Top cover  20 , retainer  24 , bottom cover  26 , and housing  30  are all molded from any suitable material such as Acrylonitrile Butadiene Styrene plastic (i.e., ABS plastic). First and second insulation layers  22  and  28  are fabricated from a suitable insulating material such as expanded polystyrene. Cooling pad  16 , contact pad  34 , and heat sink  38  are all fabricated from a suitable thermally-conductive material such as die-cast aluminum. 
         [0031]    Top cover  20  is ergonomically configured so that it may be easily held in the palm of the user&#39;s hand. In particular, top cover  20  is generally elliptical in shape when viewed from the top ( FIG. 6 ) and is convex when viewed from the end ( FIG. 3 ) or side ( FIG. 4 ). Top cover  20  has a wall  20   a  contoured to be receivable in a user&#39;s palm and thus includes a raised central region and sloping sides and ends. Top cover&#39;s sides and ends terminate in a bottom rim  20   b . Top cover  20  is substantially hollow and defines an interior chamber  20   c.    
         [0032]    First insulation layer  22  has a surface  22   a  that is configured to be substantially complementary to the interior surface of wall  20   a  of top cover  20  and first insulation layer  22  is nestingly received in interior chamber  20   c  of top cover  20 . Surface  22   a  of first insulation layer  22  abuts the interior surface of wall  20   a . First insulation layer  22  terminates in a bottom rim  22   b . Bottom surface of first insulation layer  22  defines a cavity  22   c  therein. 
         [0033]    Cooling pad  16  has a wall  16   a  that is configured substantially complementary to the bottom surface of first insulation layer  22  and cooling pad  16  is nestingly received within cavity  22   c  of first insulation layer  22 . First insulation layer  22  thus surrounds all but a portion of a bottom wall  16   b  of cooling pad  16  and thereby substantially prevents cold from escaping from cooling pad  16  into the environment other than through bottom wall  16   b . Bottom wall  16   b  preferably is slightly convex or generally horizontal except for a region adjacent an outer edge  16   c  thereof. 
         [0034]    Retainer  24  has an upper end  24   a  and a lower end  24   b . Upper end  24   a  is configured to engage bottom edge  20   b  of top cover  20 . In particular, a flange  24   c  extends upwardly and outwardly from upper rim  24   a  to interlock with bottom edge  20   b . Lower end  24   b  of retainer  24  is configured to circumscribe and engage an outer rim  16   c  of bottom wall  16   b  of cooling pad  16  and to keep cooling pad  16  locked within cavity  20   c  of top cover  20 . Lower rim  24   b  of retainer  24  defines an aperture  24   d  therein and through which a portion of bottom wall  16   b  of cooling pad  16  is accessible. It is this portion of bottom wall  16   b  that is brought into contact with the user&#39;s skin when the device  10  is used to stop a hot flash. 
         [0035]    As indicated previously, cradle  14  includes bottom cover  26 . Bottom cover  26  has an upper rim  26   a  ( FIG. 9 ) that is configured to be complementary to a bottom region of hand-held assembly  12 . That bottom region of handheld assembly  12  includes a lower surface of retainer  24  and the portion of the bottom wall  16   b  of cooling pad  16  which will be brought into contact with the user&#39;s skin. As shown in  FIG. 3 , retainer  24  preferably is slightly larger in external dimensions than is bottom cover  26  so that a lip  12   a  of hand-held assembly  12  projects outwardly beyond a side wall  14   a  of cradle  12 . Lip  12   a  makes it easier for the user to grasp assembly  12  and remove it from cradle  14 . 
         [0036]    Bottom cover  26  of cradle  14  defines a recessed region  26   b  ( FIG. 9 ) therein that is configured to receive contact pad  34  therein. Contact pad  34  is secured to bottom cover  26  in any suitable manner such as by way of fasteners  40 . Bottom cover  26  defines a pair of apertures  26   c  therein, where the apertures  26   c  are located in recessed region  26   b . Bottom cover  26  further includes a pair of flanges  26   d  that are generally semi-circular in shape and flattened. Flanges  26   d  extend downwardly from upper surface  26   a  of bottom cover  26 . 
         [0037]    Contact pad  34  has a top surface  34   a  that is complementary to bottom wall  16   b  of cooling pad  16  and a bottom surface  34   b  that is disposed adjacent an upper surface of bottom cover  26  in recessed region  26   b . When hand-held assembly  12  is docked in cradle  14 , top surface  34   a  of contact pad  34  is disposed in abutting contact with bottom wall  16   b  of cooling pad  16  and thus thermal transfer between contact pad  34  and cooling pad  16  is facilitated. 
         [0038]    A Peltier-effect element  36  is engaged in each aperture  26   c  of bottom cover  26  and extends for a distance outwardly therefrom. An upper surface  36   a  of each element  36  is disposed in thermal contact with bottom surface  34   b  of contact pad  34 . (As is known in the art, thermal grease may also be applied to the upper and lower surface of elements  36 .) The Peltier-effect elements  36  are provided as solid state heat pumps that are used to lower the temperature of the contact pad  34  to around 10 degrees Celsius. This is about ten degrees lower than a normal ambient temperature of 24 degrees Celsius. Device  10  may also be provided with a microprocessor (not shown) that is able to be programmed to cause the Peltier-effect elements  36  to cool contact pad  34  to temperatures lower or higher than 10 degrees Celsius if this was desirable or necessary for the device to function in the manner contemplated. The temperature of contact pad  34  needs to be sufficiently low enough to stimulate the cold thermoreceptors in the skin at the back of the user&#39;s neck to send a signal to the user&#39;s hypothalamus to stop the cold flash. 
         [0039]    When the Peltier-effect elements  36  are charged, as will be hereinafter described, the upper surface  36   a  thereof will be rapidly cooled and will thereby cool contact pad  34 . 
         [0040]    Second insulation layer  28  is configured to be substantially complementary to lower surface of bottom cover  26  and is engaged therewith. Second insulation layer  28  has an upper end  28   a  and a recessed region  28   b  with one or more apertures  28   c  defined therein. Apertures  28   c  are substantially shaped and located to align with apertures  26   b  of bottom cover  26 . Second insulation layer  28  also includes two flattened zones  28   c  that are shaped and located to align with flanges  26   d  on bottom cover  26  when second insulation layer  28  is disposed around bottom cover  26 . When second insulation layer  28  is engaged with bottom cover  26 , the Peltier-effect elements  36  are received through the aligned apertures  26   b ,  28   c  as is shown in  FIG. 7 . 
         [0041]    Heat sink  38  has a generally flat upper surface  38   a  that is secured adjacent a bottom surface of recessed region  28   b  of second insulation layer  28  by way of fasteners  42 . Upper surface  38   a  of heat sink  38  is in contact with a bottom surface of each Peltier-effect element  36 . As best seen in  FIG. 8 , bottom surface  38   b  of heat sink  38  includes a plurality of ridges and grooves. As will be described further herein, heat sink  38  absorbs heat emitted by the Peltier-effect elements  36  as they rapidly cool contact pad  34 . The alternating ridges and grooves in heat sink  38  provide additional surface area for heat sink  38  to dissipate heat into the surrounding environment. 
         [0042]    Housing  30  has a wall  30   a  configured to circumscribe and surround the exterior surface of second insulation layer  38  and to interlock with outer rim of bottom cover  26 . Housing  30  defines an opening  30   b  therein and through which the bottom surface  30   b  of heat sink  38  is accessible. Housing  30  also is provided with a first aperture  30   c  through which the AC-DC adapter  32  is connected, and is provided with a second aperture  30   d  through which a light emitting diode (LED)  44  is visible. Although it is not illustrated herein it should be understood that cradle  14  includes electric circuitry which operatively connects AC-DC adapter  32 , Peltier-effect elements  36  and LEDs  44 . The AC-DC adapter  32  is connected to a remote power source such as a wall outlet (not shown). A bottom edge  30   e  of housing  30  is configured into a plurality of alternating ridges and gaps, the purpose of which will be described hereafter. 
         [0043]    If provided, the microprocessor which controls device  10  is programmed to include various thermal protection override features and safety features. The microprocessor monitors and automatically shuts off device  10  if any operational issues arise. The electrical circuitry that connects the various components within cradle  14  is not shown for the sake of clarity. 
         [0044]    In use, device  10  is plugged into a source of AC power by way of AC-DC adapter  32 . LED  32  glows to indicate that the device  10  is powered. Power is applied via adapter  32  to Peltier-effect elements  36  which then become rapidly cooled on their upper surfaces  36   a . The cold is conducted into lower surface  34   b  of contact pad  34 , thereby cooling the same. At the same heat generated by devices  36  is conducted into upper surface  38   a  of heat sink  38  and is subsequently released into the surrounding environment through the gaps in bottom end  30   e  of housing  30 . Heat may also be released into a surface (not shown) upon which housing  30  rests. 
         [0045]    The cold conducted from Peltier-effect elements  36  into contact pad  34  is, in turn, conducted into cooling pad  16  when hand-held assembly  12  is engaged in cradle  14 . Because of the presence of the first insulation layer  22 , the cold in cooling pad  16  is retained therein and is not dissipated into the surrounding air. (Because of the presence of the second insulation layer  28 , the heat transferred to heat sink  38  is not transmitted upwardly into contact pad  34 .) Since Peltier-effect elements  36  are constantly powered because device  10  is plugged in, contact pad  34  and therefore cooling pad  16  are always sufficiently cold enough for use to stop a hot flash at the first sign of the same. Additionally, if hand-held assembly  12  is removed from cradle  14  and is then returned thereto, the cooling pad  16  is able to be rapidly recharged with cold by coming into contact with contact pad  34  and is therefore available for use in a matter of seconds. 
         [0046]    The flanges  26   d  on bottom cover  26  enable a user to quickly and easily locate a suitable region on device  10  at which hand-held assembly  12  may be easily grasped as they provide areas of easier access to engage lip  12   a  on assembly  12 , even in the dark. 
         [0047]    Device  10  is used in the following manner on the skin on the back of the neck of a woman at the first sign of the onset of a hot flash. The woman will lift hand-held assembly  12  off cradle  14  and, since cradle  14  is permanently plugged into an AC power source, the hand-held assembly  12  is immediately ready for use. Bottom surface  16   b  of cooling pad  16  is placed in contact with the skin at the back of the user&#39;s neck. Because cooling pad  16  is cold, the skin is cooled, thereby causing the thermoreceptors in the skin to be stimulated to a degree sufficient to emit a signal to the nervous system. Device  10  is held in a first position until the cold sensation on the neck begins to subside. This subsidence of the sensation occurs as the thermoreceptors are stimulated to a maximum degree, a condition known as saturation. Once saturation is reached, the thermoreceptors will no longer emit a signal to the brain. In order to prevent the cessation of a signal to the brain, the woman must move device  10  on her skin from the first position to a second position spaced a distance from the first position. The thermoreceptors in the skin at the second position are stimulated and thus transmit a signal to the hypothalamus. The thermoreceptors in the first area of the skin will reset themselves after a time period of about five to ten seconds. This means that after a five to ten second period, the thermoreceptors are once again in a condition where they may be stimulated and will once again emit a signal to the brain. The woman will move device back and forth between at least the first and second positions to keep the hypothalamus stimulated. The woman keeps “shuttling” the hand-held assembly  12  back and forth in this manner, holding the device in each new position until the cold sensation of the plates on the skin begins to subside, before she changes the device&#39;s position on the back of the neck. The woman will typically have to relocate assembly  12  every ten to fifteen seconds in order to have cooled plate  16  contact “new” skin where the skin&#39;s thermoreceptors have not been stimulated or have already been reset. This shuttling motion helps to keep the thermoreceptors in the skin firing signals to the hypothalamus at a maximum rate. After a time period of around sixty seconds, assembly  12  may be removed from further contact with the skin  12 . This time period of activation has been found to be sufficient to stop the symptoms of a hot flash before they are fully expressed. Hand-held assembly  12  is then repositioned on cradle  14 . 
         [0048]    It will be understood that while the device has been described specifically for reducing the effects of menopausal hot flashes, the device could be used as a heat massage device for the neck. Peltier-effect elements are constructed in such a manner that one surface, such as surface  36   a , becomes cooled and the opposite surface becomes heated. The determination as to which of the two surfaces is heated or cooled results from the polarity across the device  36 . So, for example, if one wished to heat plate  16  instead of cooling the same, the DC polarity across the Peltier-effect element  36  could be reversed. Plate  16  would then become cooled and heat sink  38  would become heated. Plate  16  could then be brought in contact with the skin to heat and/or massage the same. 
         [0049]    In the foregoing description, certain terms have been used for brevity, clearness, and understanding. No unnecessary limitations are to be implied therefrom beyond the requirement of the prior art because such terms are used for descriptive purposes and are intended to be broadly construed. 
         [0050]    Moreover, the description and illustration of the device is an example and the device is not limited to the exact details shown or described.