Abstract:
A device and method for non-invasive treatment of menopausal hot flashes includes a housing with an anatomically configured bottom wall. A Peltier effect device and heat sink are in thermal contact with a cold plate that extends from the bottom wall. As the cold plate is moved back and forth across the skin it stimulates cold thermoreceptors which signal the hypothalamus and counteract the false trigger which caused the hot flash. The cold plate, which is cooled to a temperature of around 10 degrees Celsius, is left in contact with a region of skin for no more than 10-15 seconds so that the thermoreceptors do not become saturated. The device shuts off after 1 minute.

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 cold plate that is cooled using a Peltier effect device and is moved back and forth across the back of the neck to stimulate cold thermoreceptors in the skin and to thereby counteract false triggering of the hypothalamus that 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 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 attempt 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 based 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]    There is therefore need in the art for method of controlling the menopausal symptoms commonly known as hot flashes and for a device that is used for this purpose. 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. While the present inventor is unaware of any devices or modalities that are used to control menopausal symptoms using the body&#39;s thermoregulatory system in the manner proposed in this specification as follows, the prior art has disclosed various devices and modalities for the treatment of other ailments that utilize neural pathways. Once such device and modality is disclosed in U.S. Pat. No. 5,628,769 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 patient&#39;s skin in the immediate area experiencing pain and is kept in place for a period of 15 to 20 minutes. The sensation generated by the device is felt by the patient 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. 
       SUMMARY OF THE INVENTION 
       [0008]    The device of the present invention comprises a hand-held unit that includes a housing with a solid state cooling system disposed therein. A cold plate is mounted on the housing and a least a portion thereof extends outwardly away therefrom. The cold plate is operationally connected to the cooling system and the entire cold plate is cooled by the cooling system. The cold plate is brought into abutting contact with the skin at the back of a woman&#39;s neck and is moved back and forth thereacross. The cold plate is not kept in any one position for a period of longer than 10 to 15 seconds. After 1 minute the device automatically shuts off. 
         [0009]    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 of the present invention 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 cold plate is kept in any one position 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 of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The preferred embodiments of the invention, illustrative of the best mode in which applicant has contemplated applying the principles, are set forth in the following description and are shown in the drawings and are particularly and distinctly pointed out and set forth in the appended claims. 
           [0011]      FIG. 1  is a top perspective view of the device of the present invention showing the upper and lower sections of the housing; 
           [0012]      FIG. 2  is a bottom perspective view of the device in accordance with the present invention and showing the upper and lower sections of the housing; 
           [0013]      FIG. 3  is an exploded perspective view of the device of  FIGS. 1 and 2 ; 
           [0014]      FIG. 4  is a top view of the upper section of the device; 
           [0015]      FIG. 5  is a cross-sectional side view of the device taken through line  5 - 5  of  FIG. 4 ; 
           [0016]      FIG. 6  is a side view of the device showing the recharging connector on the upper section of the housing; 
           [0017]      FIG. 7  is a bottom view of the device showing the anatomically shaped bottom wall and the cold plates mounted therein; 
           [0018]      FIG. 8  is a rear view of a woman applying the device to the back of her neck; 
           [0019]      FIG. 9  is an enlarged rear view of the device on the woman&#39;s neck with the woman&#39;s hands removed for clarity and showing the cold plates in phantom; 
           [0020]      FIG. 10  is a rear view of the woman&#39;s neck showing the device being moved in a first direction across the neck from a first position to a second position; and 
           [0021]      FIG. 11  is a rear view of the woman&#39;s neck showing the device being moved in a second direction across the neck and from the second position to a third position. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    Referring to  FIGS. 1-7  there is shown a medical device in accordance with the present invention and being generally indicated at  10 . Device  10  comprises a housing  12  made up from an upper section  12   a  and a lower section  12   b  that are interlockingly engaged with each other. Each of the upper and lower sections  12   a,    12   b  preferably is molded from any suitable material such as Acrylonitrile Butadiene Styrene plastic (i.e., ABS plastic) and the sections are configured to snap fit together. Upper and lower sections  12   a,    12   b  are configured to define an interior chamber  13  ( FIG. 4 ) which houses a plurality of components as will be hereinafter described. When device  10  is assembled, lower section  12   b  is configured to be brought into abutting contact the back of a patient&#39;s neck and the upper section is configured to be easily gripped in the palm of one hand. 
         [0023]    Upper section  12   a  includes an exterior wall comprising a raised central portion  14 , two transition zones  16  sloping sharply downwardly from central portion  14 , and two exterior surfaces  18  that slope downwardly away from the transition zones  16  and in opposite directions from each other. The contoured shape of upper section  12   a  helps the device  10  to be easily seated within the palm of one hand. Transition zones  16  provide suitable areas on device  10  for a person to place their thumb and fingers should they wish to grip the device in that manner. Additionally, the side walls  20  of upper section  12   a  are configured to enable the user to easily grip device  10  between their thumb and fingers if they wish to grip the device in that manner. Upper section  12   a  is provided with buttons  22 ,  24  thereon for operating an on/off switch  26  and a recharging connector  28  that are disposed within the interior chamber  13  of housing  12 . 
         [0024]    Lower section  12   b  of housing  12  includes a bottom wall  30  and a perimeter wall  32  that extends upwardly away from bottom wall  30 . Perimeter wall  32  is shaped to interlockingly engage portions of side walls  20  and exterior surfaces  18 . Bottom wall  30  is configured to be anatomically shaped to fit the rear curvature of a person&#39;s neck.  FIGS. 6 &amp; 7  show that bottom wall  30  has a central region  30   a  flanked by two side regions  30   b,    30   c  that angle downwardly away from central region  30   a.  This shape permits bottom wall  30  to remain in abutting contact with the back of the neck as device  10  is moved thereacross, as will be hereinafter described. 
         [0025]    The interior surface of bottom wall  30  preferably includes one or more dividers  34  that extend upwardly away therefrom. These dividers  34  separate lower section  12   b  into compartments  36 ,  38 ,  40  which make it easier to house the operating components of device  10 . These components include a power source  42  that is retained within compartment  38 . In the preferred embodiment of the invention, the power source comprises one or more rechargeable NiCad batteries. Preferably, power source  42  comprises four rechargeable NiCad batteries.  FIG. 6  shows a rear view of device  10  and shows the connector  28  into which one of a remote recharging unit (not shown) or AC supply may be operationally connected in order to recharge the batteries. It will be understood that any other suitable power source may, alternatively, be utilized in device  10  other than the rechargeable batteries. 
         [0026]    Device  10  is also provided with a circuit board  44  in chamber  13 . Circuit board  44  includes the on/off switch  26 , the recharging connector  28 , a LED light  46  to indicate whether the device is on or off, and a microprocessor  48 . Microprocessor  48  controls device  10  and includes various thermal protection override features and safety features. Microprocessor  48  monitors the battery charge level and automatically shuts off device  10  if any operational issues arise. The electrical circuitry that connects circuit board  44  to the other components within housing  12  is not shown for the sake of clarity. 
         [0027]    In accordance with a specific feature of the present invention, lower section  12   b  defines at least one and preferably two apertures  50  defined in bottom wall  30 . Preferably each aperture  50  is defined in one of the regions  30   b,    30   c  of bottom wall  30 . Apertures  50  open into the interior chamber  13  and specifically into compartments  36  and  40 , respectively. Device  10  further includes at least one, and preferably two cold plates  52 . Each cold plate  52  is fixedly mounted within one of apertures  50  in such a manner that the cold plates  52  extend slightly outwardly beyond the regions  30   b,    30   c  of bottom wall  30  as shown in  FIG. 5 . Each cold plate  52  preferably is substantially rectangular in shape and is around 1″×1.5″ in size. Central region  30   a  is of a width that is greater than the width of each plate  52 . Thus, central region  30   a  is of a width that is greater than one of 1″ and 1.5″, depending on the orientation of plates  52 . The entire surface area of cold plates  52  that extends outwardly from beyond bottom wall  30  is designed to contact the patient&#39;s skin. In the preferred embodiment of the invention, cold plates  52  are manufactured from aluminum, but it will be understood that plates  52  may be made from any thermally conductive material. 
         [0028]    In accordance with yet another specific feature of the present invention, device  10  is provided with a solid state cooling system which includes one, but preferably two, Peltier effect elements  54  and one, but preferably two, heat sinks  56 . In the preferred embodiment, heat sinks  56  are manufactured from aluminum but they may alternatively be manufactured from copper or any other suitable material known in the art. A first Peltier element  54  and heat sink  56  is disposed in compartment  36  and a second Peltier element  54  and heat sink  56  is disposed in compartment  40 . Each Peltier element  54  is disposed between one of the cold plates  52  and one of the heat sinks  56 . The Peltier elements  54  are in thermal contact with the associated cold plate  52  and heat sink  56 . If elements  54  are in direct abutting contact with cold plates  52  and heat sinks  56 , a suitable thermal grease may be applied therebetween as is known in the art. Each Peltier element  54  is electrically connected to power source  42  by a pair of wires  58 . The Peltier elements  54  are provided as solid state heat pumps that are used to lower the temperature of the entire cold plates  52  or at least the entire skin-contacting surface of the cold plates  52 . In the preferred embodiment, Peltier elements  54  lower the temperature of cold plates  52  to a temperature of around 10 degrees Celsius. This is about ten degrees lower than a normal ambient temperature of 20 degrees Celsius. It will be understood that the microprocessor could be programmed to cause the Peltier effect devices  54  to cool cold plates  52  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 cold plates  52  needs to be sufficiently low enough to stimulate cold thermoreceptors in the skin at the back of the neck to send a signal to the hypothalamus. 
         [0029]    Referring to  FIGS. 8-11 , the device  10  is used in the following manner on the skin on the back of the neck  100  of a woman  110 . When the woman  110  feels the onset of a hot flash, she depresses the button  22  on upper section  12   a  thereby activating the on/off switch  26  for device  10 . This activation applies a voltage across the Peltier effect devices  54  causing a rapid drop in temperature of the surfaces  54   a  ( FIG. 5 ) thereof that are in contact with cold plates  52 . Surfaces  54   a,  in turn, cool cold plates  52  in a time period of between three and five seconds. The woman  110  then holds device  10  in her hand  112  and places bottom wall  30  of device  10  in contact with the back of her neck  100  as is illustrated in  FIG. 8 .  FIG. 9  shows the top of device  10  with cold plates  52  shown in phantom and with the woman&#39;s hand removed therefrom for the sake of clarity. It will be understood that the skin  100  situated in the region of the neck that is in abutting contact with cold plates  52  is cooled by contact with cold plates  52 . This causes the thermoreceptors in the skin to be stimulated to a degree sufficient to emit a signal to the nervous system. Heat from the skin  100  is conducted into cold plates  52  and via Peltier elements  54  to heat sinks  56 . Device  10  is held in this first position shown in  FIG. 9  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  110  must move device  10  on her skin  100  from the first position to a second position. This is illustrated in  FIG. 10  where device  10  is moved in a first direction A across skin  100  to a second position. In this second position, cold plates  52  are disposed in contact with a new region of skin in which the thermoreceptors have not yet been stimulated. The previously cooled regions of skin that were cooled when the device was in the first position are illustrated in  FIG. 10  as areas B. The thermoreceptors in areas B 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. 
         [0030]    The temperature of cold plates  52  on device  10  remains substantially constant because of the thermal transfer of heat from plates  52  through the Peltier effect device  54  to heat sinks  56 . Consequently, when device  10  has been moved in direction A, the new regions of skin  100  that are disposed beneath the cold plates  52  when device  10  is in this second position are cooled by contact with plates  52 . When the cold sensation on the neck begins to subside once again because the thermoreceptors in this second region have become saturated, the woman  110  must move device  10  to a third position in a different location. Accordingly, as is shown in  FIG. 11 , device  10  may be moved in a second direction C so that cold plates  52  are disposed in contact with a new region of skin  100 . This new region of skin may be region B, where the thermoreceptors have been automatically reset by the body, or may be a totally different region of skin. The regions of skin that were cooled when device  10  was in the second position shown in  FIG. 10  are indicated in  FIG. 11  as regions D. Once cold plates  52  have been removed from regions D, the thermoreceptors in the skin in those regions are reset by the body after five to ten seconds. The cold plates  52  are spaced a distance away from each other on bottom wall  30 . This balances the desirability of providing the greatest possible area of contact between the cold plates  52  and the skin while still providing sufficient areas of the skin that are not contacted by the plates  52  so that the thermoreceptors in the previously cooled areas have sufficient time to reset without a substantial drop in the neural signal strength to the brain. 
         [0031]    The woman  110  keeps “shuttling” the device  10  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  110  will typically have to relocate the device  10  every ten to fifteen seconds in order to have device  10  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, device  10  automatically shuts off. This time period of activation has been found to be sufficient to stop the symptoms of a hot flash before they are fully expressed. If the hot flash ceases before the automatic shutoff of the device  10 , the woman  110  may simply depress button  22 , thereby depressing the on/off switch  26  and deactivating device  10 . 
         [0032]    While the preferred embodiment of the present invention has been described as having two cold plates that are each in abutting contact with a separate Peltier effect device, which in turn are in operational contact with a separate heat sink, it will be understood that the device may include one or more cold plates that are in contact with a single Peltier effect device that is in turn in operational connection with a single heat sink. Furthermore, the device may include more than one cold plate, each of which is in contact with its own Peltier effect device, and that the more than one Peltier effect devices may be in operational contact with a single heat sink. The device may further include other components that aid in dissipating heat from the heat sink such as openings in the housing, fans etc. 
         [0033]    Microprocessor  48  monitors the temperature of various components within device  10 , and more specifically the temperature of heat sinks  56 . If the monitored temperatures are above a preset, pre-determined level, then microprocessor  48  will prevent activation of device  10 . 
         [0034]    It will be understood that while the device of the present invention has been described specifically for reducing the effects of menopausal hot flashes, the device could be used as a heated massage device for the neck. Peltier effect devices are constructed in such a manner that one surface, such as surface  54   a  ( FIG. 5 ), becomes cooled and the opposite surface  54   b  becomes heated. The determination as to which of the two surfaces  54   a,    54   b  is heated or cooled results from the polarity across the device  54 . So, for example, if one wished to heat plate  52  instead of cooling the same, the DC polarity across the Peltier effect device  54  could be reversed. Plate  54   b  would then become cooled and plate  54   a  would become heated, thus heating plate  52  and thereby the skin within which that plate is in contact. 
         [0035]    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. 
         [0036]    Moreover, the description and illustration of the invention is an example and the invention is not limited to the exact details shown or described.