Patent Publication Number: US-2015066119-A1

Title: Infant warming systems

Description:
FIELD OF THE INVENTION 
     The present invention relates to medical devices. In particular, the present invention relates to methods and apparatus for facilitating and monitoring infant warming systems. More particularly, the present invention relates to methods and apparatus for facilitating and monitoring infant warming systems which utilize phase change materials for providing and maintaining an elevated temperature to an infant. 
     BACKGROUND OF THE INVENTION 
     Babies who are born prematurely, with low-birth-weight (LBW), or weak and ill-developed, may have a particularly difficult time regulating body temperature because their nervous regulating mechanisms are often underdeveloped. If heat loss is not prevented and is allowed to continue, such babies will develop hypothermia. A hypothermic baby, especially if it is small, sick, or is of LBW, is at increased risk of developing health problems and of dying. 
     Twenty million premature and LBW babies susceptible to thermoregulation problems are born every year around the world. In developed countries, LBW babies are placed in incubators to regulate their temperature. Typical incubators are very expensive, costing thousands of US dollars. Such incubators require active electrical connections and may require delicate electronics. 
     Various warming devices may be utilized to warm infants and particularly newborn infants in order to maintain the infant&#39;s body temperature within a predetermined range. Such infant warmers commonly radiant heaters which radiate infrared energy upon the infant to maintain the predetermined temperature. However, such conventional infant warmers rely on a constant source of electricity in order to remain operational yet in many regions of the world, such as developing countries, such electrical sources may be unavailable or unreliable. 
     Other devices have included the use of electric blankets which incorporate resistive heating elements in order to produce the desired heat. Yet such electric blankets not only require a similar electrical source but also fail to distribute heat evenly and may further require sophisticated electronics to regulate heat. 
     While other devices have been used which utilize heat exchange materials for regulating body temperature, such devices have been unsuitable for use in heating and/or maintaining the body temperature for infants. This is particularly the case since infants have a relatively narrow temperature range in which their bodies should be maintained. 
     Hence, there remains a need for improved thermal regulation apparatus and methods that address the problems associated with existing thermal regulation designs. 
     SUMMARY OF THE INVENTION 
     An infant warming assembly which utilizes a phase change material (PCM) may be used to warm the infant without the need for electricity. Such a system may comprise a temperature regulation assembly for regulating the temperature of an infant, generally comprising a phase change material which changes between a liquid phase and a solid phase within a predetermined temperature range, at least one temperature sensor in thermal communication with the phase change material, and a control/indicator interface in communication with the at least one temperature sensor, the interface being programmed to provide an indication or alert to a user when the phase change material is within the predetermined temperature range. 
     In use, the system may generally implement methods of regulating temperature of an infant by providing a temperature regulation assembly having a phase change material which changes between a liquid phase and a solid phase within a predetermined temperature range, positioning the temperature regulation assembly within a retaining pouch of a heating assembly having an adjacent reservoir filled with a heated volume of water, providing an indication or alert when a temperature of the temperature regulation assembly is between 35° to 41° C., and further positioning the temperature regulation assembly within a retaining pouch of a bedding such that the temperature of the infant in contact with the bedding is regulated. 
     Further examples of an infant warmer utilizing a PCM are shown in further detail in U.S. Pat. No. 8,257,417; U.S. Pub. 2012/0305231; and U.S. 201210330388, each of which is incorporated herein by reference in its entirety and for any purpose. Moreover, various features shown and described in each of the incorporated references may be combined in any number of combinations with the various features disclosed herein. 
     One variation of the infant warming assembly may generally comprise a temperature regulation assembly to which a control/indicator interface may be attached for monitoring various parameters of the assembly. The temperature regulation assembly (once suitably heated) may be positioned within a retaining pouch defined along a bedding which may optionally include one or more straps for securing the infant. The retaining pouch defined in the bedding may separate the temperature regulation assembly from the infant but maintains thermal coupling with the infant. An additional bed sheet (e.g., fabricated from cotton) may also be optionally placed around or upon the bedding for contact against the infant&#39;s body to prevent any skin reaction from being induced upon the infant&#39;s body. 
     When the newborn is placed upon the bedding, the infant warming assembly provides warmth such that a warm microclimate is created around the newborn while also providing the newborn warmth through dorsal thermal conduction from the temperature regulation assembly. Once heated, the infant warming assembly may maintain a temperature of about, e.g., 37° C., for about, e.g., 8 hours, without needing to be re-heat the temperature regulation assembly. Moreover, such a warming assembly may be used in a variety of ambient conditions varying from a temperature range of, e.g., 10° to 34° C., with a humidity range of, e.g., 30% to 75%. 
     The heating assembly may incorporate a fluid reservoir having a port into which a heated fluid, e.g., 2.7 to 3 liters of boiling water, may be poured into. A funnel may be optionally positioned within or in proximity to the port for facilitating the introduction of the water into the reservoir. It is this heated water retained within the reservoir which serves as the source of warmth to elevate the temperature regulation assembly to its operating temperature. Once the reservoir is filled, the temperature regulation assembly may be positioned adjacent to the reservoir and separated but still in thermal communication. An interface attachment, such as a flap, may extend from the heating assembly and connect or couple to the control/indicator interface to optionally silence any alarms or alerts on the interface. With the assembly suitably positioned and retained within the retaining pouch, the heating assembly may be laid on a flat surface to allow the PCM contained within the assembly to absorb the heat via thermal conduction and/or convection from the heated water in the adjacent reservoir. 
     Under normal operating conditions, the temperature regulation assembly  12  may take, e.g., about 45 minutes, to heat within the heating assembly  30  to a suitable operating temperature for use. However, if the assembly is re-heated after use, it may take about, e.g., 20 minutes or less, to re-heat back to its desired operating temperature. 
     When the temperature regulation assembly  12  has reached its operating temperature, the control/indicator interface may indicate through a visual and/or auditory alarm (e.g., changing from a flashing red light to a flashing green light and/or with a beeping alert) that the assembly is ready for use. The temperature regulation assembly may then be removed from the heating assembly and inserted into the retaining pouch of the bedding for use. 
     The bedding itself may be insulated to minimize heat loss from the temperature regulation assembly. The one or more straps extending over the bedding may be adjustably tightened or loosened, e.g., via hook-and-loop fasteners, hooks, buttons, etc., around the infant for ensuring close contact with the infant body as well as securing the infant in place. The top surface of the bedding may be made of a water-resistant material that facilitates cleaning of the bedding. Moreover, bunting may be provided around the periphery of the bedding to further prevent the infant from rolling off the bedding while still allowing for complete access and visibility to the parent or care provider. Additionally, the open design of the bedding further allows for close parent-to-child interaction even when placed upon the bedding. Moreover, the bedding may further ensure that the heat provided by the temperature regulation assembly is dispersed and evenly distributed over the bedding to the infant and may further ensure that the temperature regulation assembly stays warm for about, e.g., 8 hours or more. 
     Aside from the PCM material, the assembly may also comprise an enclosed layer of water which is positioned atop of the PCM to provide for further support to the infant as well as to ensure that the heat and temperature is uniformly distributed over the assembly. The assembly may be comprised of a retaining tray which defines a PCM retaining portion surrounded by a retaining edge or lip around the periphery of the tray. One or more temperature sensors, e.g., thermistor, thermocouple, etc., may be positioned along the retaining tray to monitor the temperature of the PCM. 
     The retaining tray may provide a retaining channel or depression for the temperature regulation element which may enclose the PCM. The PCM may generally comprise a substance which melts or solidifies at a particular temperature or temperature range thereby storing or releasing energy at that particular temperature or range. During a phase change from liquid to solid or vice versa, the energy absorbed or released by the PCM is used to facilitate the phase change of the material and thus the temperature of the PCM remains constant. The PCM preferably has a high heat of fusion which allow it to store and release large amounts of energy. Additionally, the PCM may comprise either an organic or inorganic material, e.g., n-eicosane, Tetradecanol, eutectic mixtures, or any other suitable material. 
     While the temperature regulation element may continue to provide heat at its operating temperature (e.g., for about 8 hours or more at an ambient temperature of about 25° C.), the heat-providing capacity of the temperature regulation element may depend on factors such as weight and health of the newborn as well as operating conditions such as ambient temperature, as described in further detail below. With the temperature regulation element so positioned within retaining portion, a separate tray covering may be secured to the retaining edge or lip around the periphery of the tray to fully enclose the temperature regulation element within the tray. 
     With the temperature regulation element fully enclosed, a separate water layer retained within an enclosure may then be secured upon the tray covering. The water layer may provide for further support to the infant as well as to ensure that the heat and temperature is uniformly distributed over the assembly. The fully assembled temperature regulation assembly may accordingly be heated (and re-heated as needed) within the retaining pouch of heating assembly and then transferred to the retaining pouch of the bedding. Once the temperature regulation assembly is placed within bedding for use with an infant, the PCM within temperature regulation element may provide for warming heat for up to 8 hours or more. 
     Turning now to the control/indicator interface, the interface may comprise a processor and associated electronics within which continuously monitor both the temperature of the temperature regulation assembly as well as the ambient temperature. In the event that the various temperatures are too high or too low for any reason, the interface may provide a visual and/or auditory indicator or alarm to alert the user to take corrective action, if needed, such as when the temperature regulation assembly is safe to use with an infant (e.g., a green light may flash) or when the temperature regulation assembly is unsafe due to high or low temperatures (e.g., a red light may flash with or without an auditory alarm). The indicator may be powered by an on-board power supply, e.g., batteries, or any other type of power supply. 
     The control/indicator interface may also incorporate memory storage to collect and store various forms of data monitored and sensed by the system or user as well as a communication interface to transfer the data (e.g., wired or wirelessly) to or from an external device. 
     The indicator may also be provided with one or more actuation features, such as a button, touchscreen, etc. to place the processor within the indicator within one of several available functions. A first function may silence or “snooze” any visible and/or audible alarms for about, e.g., 1.5 minutes, although this period of time may be programmed to be more or less. A second function of the indicator may be used when the assembly is in use with an infant. When activated, a PCM charge indication feature may allow the user to estimate how long the assembly will last so that the user may plan accordingly. Finally, a third function may initiate a demonstration mode after which the indicator may revert to its normal state. 
     Because of the differences between the temperature of the assembly and the variability of the ambient temperature, the processor within indicator may be programmed to follow one of several different algorithms to ensure safety to the infant. The indicator may be programmed to distinguish when the assembly is positioned inside the receiving pouch of the heating assembly (e.g., when the interface attachment is coupled to the indicator). Similarly, the indicator may also be programmed to distinguish when the assembly is positioned outside of the heating assembly such as when the unit is simply removed from the heating assembly or when the unit is placed within the receiving pouch of the bedding for use as shown by the various states within block. 
     When the assembly is positioned within the heating assembly, it may comply with one of several different states. For instance, prior to or during heating of the assembly, the assembly may be indicated as being in a COLD state, e.g., by showing a red light and remaining silent, until its temperature is sensed by indicator as being below 36.0° C. In the event its temperature rises to be greater than or equal to 36.5° C. indicator may enter an OK TO USE state, e.g., by showing a green light and alerting with a Medium Priority alarm. However, if the assembly becomes overheated and unsafe for use, indicator may enter an OVERHEATED state, e.g., by showing a red light and alerting with a High Priority alarm (which may or may not be optionally silenced). The assembly may be considered overheated if the sensed temperature is either greater than or equal to 41° C. or if the sensed temperature is greater than or equal to 38.5° C. along with a temperature rate change over time (dT/dt) of 0.2 degrees/30 seconds is also detected. However, if the temperature falls below 40.5° C. along with a negative temperature rate change over time, then the indicator may revert to its OKAY TO USE state. 
     Because use of the assembly may be affected by the ambient temperature, the indicator may also be configured to sense the ambient temperature as well and account for this variable condition. For instance, in the event that a HIGH AMBIENT state is detected (e.g., when the ambient temperature is greater than or equal to 32° C.), the indicator may show a red light yet remain silent if the assembly is still positioned within the heating assembly. If the temperature of the assembly is sensed to be greater than or equal to 41° C., then the indicator may enter the OVERHEATED state. Otherwise, if the ambient temperature is less than or equal to 32° C. and the detected ambient temperature remains so for greater than 2 minutes, then the indicator may enter into a COLD or OK TO USE state. The 2 minute waiting period may be programmed into the indicator to ensure that any temporary temperature fluctuations are dampened and accounted for although this waiting period may be less than or greater than 2 minutes or may be omitted entirely if so desired. 
     In the event that the temperature regulation assembly has been removed from the heating assembly, e.g., for use within the bedding, then the indicator may indicate or alert any one of the states shown in block. For instance, in the event that a temperature of the assembly is less than 35° C., a COLD state may be indicated, e.g., by showing a red light and indicating a High Priority alarm, to alert the user that the assembly requires heating and should not be used with an infant. 
     However, if the assembly is sensed to fall below 35.3° C. during its use, then an EARLY HEATING INDICATION state may be indicated, e.g., by showing a green light and alerting with an optional repeating alert or alarm, to alert the user that the assembly may need to be re-heated within a predetermined period of time, e.g., within 30 minutes, to allow the user to make preparations accordingly such as by heating water for the heating assembly. If the assembly is sensed to further fall below 35.0° C., then it may re-enter the COLD state; otherwise, if the assembly is sensed to rise to be greater than or equal to 36° C., then the indicator may enter an OK TO USE state. However, in the event that the assembly is sensed to rise in temperature to be greater than or equal to 41° C. then the indicator may enter an OVERHEATED state, e.g., by showing a red light and alerting with a High Priority alarm, to alert the user that the assembly should not be used with the infant and should be allowed to cool before use. If the indicator senses that the temperature has fallen below 38.5° C. then the indicator may enter back into its OK TO USE state. 
     Because use of the assembly may be affected by the ambient temperature as sensed by the indicator, an additional state may be accounted for as shown by the HIGH AMBIENT state. Additionally, with the various states (when the assembly is either within the heating assembly or outside the heating assembly), the temperature regulation assembly may be re-positioned between the heating assembly and bedding (or simply removed from the heating assembly). 
     Additionally and/or alternatively, the system may also incorporate a number of features to further provide for the safety and comfort of the infant placed within the system. For instance, the control/interface unit may alert to conditions such as the ambient temperature being too low or too high or it may automatically trigger other actions that ensure usage of the device when in a safe ambient temperature range. Moreover, the system may also incorporate one or several monitoring peripherals to monitor various physiological parameters of the infant (e.g., vital parameters such as infant temperature, weight, oxygen levels, respiration, heart rate, etc.). Additionally, any number of monitoring and/or peripheral devices, e.g., air-purifiers, may be used in combination with the system and optionally connected to the control/indicator interface (e.g., wired or wirelessly). Such devices may be used to help create or maintain hygienic levels of air quality (in one example) around the infant. Other devices may be used in other examples such as ambient warmers, humidity controllers, etc. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  show top and perspective assembly views of one variation of an infant warming assembly utilizing several components. 
         FIG. 2  shows a perspective assembly view of the several components which may be utilized in the infant warming assembly. 
         FIG. 3  shows a perspective view of an infant bedding having an optional retaining strap and pouch for receiving a temperature regulation assembly. 
         FIG. 4  shows a perspective view of one variation of a temperature regulation assembly having a control/indicator interface for monitoring a temperature of the assembly. 
         FIGS. 5A to 5C  show perspective, top, and side views of a retaining tray for holding a temperature regulation element. 
         FIG. 5D  shows a perspective view of a retaining tray with a temperature regulation element positioned within the tray. 
         FIG. 5E  shows a top view of a tray covering which may be attached to the retaining tray for maintaining a position of the temperature regulation element. 
         FIGS. 5F and 5G  show perspective views of a temperature regulation assembly prior to assembly with the control/indicator interface and with the interface attached. 
         FIG. 6  shows a perspective view of a heating assembly which may be used to heat the temperature regulation assembly. 
         FIG. 7  shows a partial cross-sectional top view of a reservoir which may be contained within the heating assembly for retaining a heated fluid such as water for heat transfer to the temperature regulation assembly. 
         FIG. 8  shows a top assembly view of the heating assembly having the temperature regulation assembly contained within for heating of the temperature regulation element. 
         FIG. 9  shows a graph of the temperature change over time of the temperature regulation element. 
         FIG. 10  shows a chart illustrating examples of the various types of indications and/or alerts which may be displayed by the control/indicator interface. 
         FIG. 11  shows a flow diagram of the various heating and regulation modes of the temperature regulation assembly which may be monitored by the control/indicator interface. 
         FIG. 12  shows the diagram of  FIG. 11  illustrating the various states between which the temperature regulation assembly may be re-positioned. 
         FIG. 13  shows a top view of an infant placed within a heating assembly and an optional monitoring peripheral attached to the infant and control/indicator interface. 
         FIG. 14  shows a top view of an infant placed within the heating assembly and an optional monitoring and/or peripheral device in communication with the control/indicator interface. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In elevating and maintaining the temperature of an infant, particularly of a low birth weight newborn infant weighing, e.g., 1.5 to less than 2.5 kilograms, an infant warming assembly which utilizes a phase change material (PCM) may be used to warm the infant without the need for electricity. Such a system may be effective and simple enough to use by parents at the infant&#39;s home or in a clinical environment by medical staff and in settings where electrical power may be unavailable or uncertain. Because electrical power is not needed to heat and maintain the phase change material at an elevated temperature, the possibility of burns near the infant are also eliminated. 
     Further examples of an infant warmer utilizing a PCM are shown in further detail in U.S. Pat. No. 8,257,417; U.S. Pub. 2012/0305231; and U.S. 2012/0330388, each of which is incorporated herein by reference in its entirety and for any purpose. Moreover, various features shown and described in each of the incorporated references may be combined in any number of combinations with the various features disclosed herein. 
     One variation of the infant warming assembly  10  may generally comprise a temperature regulation assembly  12  to which a control/indicator interface  14  may be attached for monitoring various parameters of the assembly  12 . The temperature regulation assembly  12  (once suitably heated) may be positioned within a retaining pouch  20  defined along a bedding  16  which may optionally include one or more straps  18  for securing the infant, as shown in the top view of  FIG. 1A . The retaining pouch  20  defined in the bedding  16  may separate the temperature regulation assembly  12  from the infant but maintains thermal coupling with the infant.  FIG. 1B  shows a perspective assembly view of the warming assembly  10  having the temperature regulation assembly  12  partially removed from the retaining pouch  20  of bedding  16  to illustrate the insertion and positioning of the assembly  12  within the bedding  16 . An additional bed sheet  22  (e.g., fabricated from cotton) may also be optionally placed around or upon the bedding  16  for contact against the infant&#39;s body to prevent any skin reaction from being induced upon the infant&#39;s body. Because the bed sheet  22  is replaceable, cleaning of the warming assembly  10  is further simplified. 
     When the newborn is placed upon the bedding  16  with the bed sheet  22  and is covered with a blanket, the infant warming assembly  10  provides warmth such that a warm microclimate is created around the newborn while also providing the newborn warmth through dorsal thermal conduction from the temperature regulation assembly  12 . Once heated, the infant warming assembly  10  may maintain a temperature of about, e.g., 37° C. for about, e.g., 8 hours, without needing to be reheat the temperature regulation assembly  12  (which is the same temperature range as recommended by the World Health Organization for a heated water mattress). Moreover, such a warming assembly  10  may be used in a variety of ambient conditions varying from a temperature range of, e.g., 10 °  to 34° C. with a humidity range of e.g., 30% to 75%. 
       FIG. 2  shows a perspective assembly view of the various components which may be used in operating the infant warming assembly  10 . As shown, the removable bed sheet  22  is shown removed from the bedding  16 . Also, the temperature regulation assembly  12  is also shown removed from the retaining pouch  20  of bedding  16 . Additionally, a variation of the heating assembly  30  is shown which may be utilized to heat the temperature regulation assembly  12  to an elevated temperature prior to insertion within the retaining pouch  20  of bedding  16  for use with the infant. The heating assembly  30  may incorporate a fluid reservoir  32  having a port  34  into which a heated fluid, e.g., 2.7 to 3 liters of boiling water, may be poured into. A funnel  39  may be optionally positioned within or in proximity to the port  34  for facilitating the introduction of the water into the reservoir  32 . The funnel  39  may further define a visual indicator such as a marking or graduation along the funnel as a fill indicator to provide the user a visual indication as to when the reservoir  32  is sufficiently filled with the heated water. 
     It is this heated water retained within the reservoir  32  which serves as the source of warmth to elevate the temperature regulation assembly  12  to its operating temperature. Once the reservoir  32  is filled, the temperature regulation assembly  12  may be positioned adjacent to the reservoir  32  and separated but still in thermal communication. An interface attachment  38 , such as a flap, may extend from the heating assembly  30  and connect or couple to the control/indicator interface  14  to optionally silence any alarms or alerts on the interface  14 . With the assembly  12  suitably positioned and retained within the retaining pouch  36 , the heating assembly  30  may be laid on a flat surface to allow the PCM contained within the assembly  12  to absorb the heat via thermal conduction and/or convection from the heated water in the adjacent reservoir  32 . 
     Under normal operating conditions, the temperature regulation assembly  12  may take, e.g., about 45 minutes, to heat within the heating assembly  30  to a suitable operating temperature for use. When the temperature regulation assembly  12  has reached its operating temperature, the control/indicator interface  14  may indicate through a visual and/or auditory alarm (e.g., changing from a flashing red light to a flashing green light and/or with a beeping alert) that the assembly  12  is ready for use, as described in further detail below. The temperature regulation assembly  12  may then be removed from the heating assembly  30  and inserted into the retaining pouch  20  of bedding  16  for use. 
     If the ambient environment is exceptionally cold, it can take about, e.g., 1 hour or more, for the heating temperature regulation assembly  12  to heat the temperature regulation assembly  12  to its suitable operating temperature. However, during continuous use it may take only, e.g., about 15 to 20 minutes or less, to reheat the temperature regulation assembly  12  that has only recently started to indicate an overcooled state, as described in further detail below. 
       FIG. 3  shows a perspective view of the bedding  16  with the retaining pouch  20  into which the temperature regulation assembly  12  may be inserted. The bedding  16  itself may be insulated to minimize heat loss from the temperature regulation assembly  12 . The one or more straps  18  extending over the bedding  16  may be adjustably tightened or loosened, e.g., via hook-and-loop fasteners, hooks, buttons, etc., around the infant for ensuring close contact with the infant body as well as securing the infant in place. The top surface of the bedding  16  may be made of a water-resistant material that facilitates cleaning of the bedding  16 . Moreover, bunting may be provided around the periphery of the bedding  16  as shown to further prevent the infant from rolling off the bedding  16  while still allowing for complete access and visibility to the parent or care provider. Additionally, the open design of the bedding  16  further allows for close parent-to-child interaction even when placed upon the bedding  16 . Moreover, the bedding  16  may further ensure that the heat provided by the temperature regulation assembly  12  is dispersed and evenly distributed over the bedding  16  to the infant and may further ensure that the temperature regulation assembly  12  stays warm for about, e.g., 8 hours or more. 
     Turning now to the temperature regulation assembly  12  itself, the assembly  12  and the attached interface  14  may be seen in the perspective view of  FIG. 4 . Aside from the PCM material, assembly  12  may also comprise an enclosed layer of water which is positioned atop of the PCM to provide for further support to the infant as well as to ensure that the heat and temperature is uniformly distributed over the assembly  12 . The assembly  12  may be comprised of a retaining tray  40  which defines a PCM retaining portion  42  surrounded by a retaining edge or lip  46  around the periphery of the tray  40 , as shown in the perspective view of  FIG. 5A  as well as the top and side views of  FIGS. 5B and 5C . One or more temperature sensors  44 , e.g., thermistor, thermocouple, etc., may be positioned along the retaining tray  40  to monitor the temperature of the PCM. 
     While the retaining tray  40  may be comprised of various materials, it may be fabricated from, e.g., PVC, and have a thickness of, e.g., 0.7 mm. Moreover, the tray  40  may have an overall length of, e.g., 415 mm, an overall width of, e.g., 245.5 mm, as shown in  FIG. 5B , as well as a height of e.g., 25.4 mm, as shown in  FIG. 5C . The dimensions provided are merely exemplary and may be varied depending upon the desired overall dimensions. 
     The retaining tray  40  may provide a retaining channel or depression for the temperature regulation element  50  which may enclose the PCM. The PCM may generally comprise a substance which melts or solidifies at a particular temperature or temperature range thereby storing or releasing energy at that particular temperature or range. During a phase change from liquid to solid or vice versa, the energy absorbed or released by the PCM is used to facilitate the phase change of the material and thus the temperature of the PCM remains constant. The PCM preferably has a high heat of fusion which allow it to store and release large amounts of energy. Additionally, the PCM may comprise either an organic or inorganic material, e.g., n-eicosane, Tetradecanol, eutectic mixtures, or any other suitable material. 
     While the temperature regulation element  50  may continue to provide heat at its operating temperature (e.g., for about 8 hours or more at an ambient temperature of about 25° C.), the heat-providing capacity of the temperature regulation element  50  may depend on factors such as weight and health of the newborn as well as operating conditions such as ambient temperature, as described in further detail below. 
     With the temperature regulation element  50  so positioned within retaining portion  42 , as shown in  FIG. 5D , a separate tray covering  52  may be secured to the retaining edge or lip  46  around the periphery of the tray  40  to fully enclose the temperature regulation element  50  within the tray  40 . The tray covering  52 , as shown in the top view of  FIG. 5E , may be similarly fabricated from PVC with a thickness of 0.5 mm and similar dimensions to the retaining tray  40 . Moreover, the tray covering  52  not only secures the temperature regulation element  50  within the assembly  12  but also maintains a flattened configuration of the element  50  and prevents the element  50  from forming a bulged or tear-drop shape. 
     With the temperature regulation element  50  fully enclosed, a separate water layer  56  retained within an enclosure may then be secured upon the tray covering  52 , as shown in the top view of  FIG. 5F . As described above, the water layer  56  may provide for further support to the infant as well as to ensure that the heat and temperature is uniformly distributed over the assembly  12 . The interface attachment  54  may also be seen with wires extending from the temperature sensor  44  within the retaining tray  40 . The control/indicator interface  14  may then be attached to the retaining tray  40  and electrically coupled to the temperature sensor  44  within, as shown in the perspective view of  FIG. 5G . 
     The fully assembled temperature regulation assembly  12  may accordingly be heated (and re-heated as needed) within the retaining pouch  36  of heating assembly  30  and then transferred to the retaining pouch  20  of bedding  16 .  FIG. 6  shows a perspective view of heating assembly  30  and  FIG. 7  shows a partial cross-sectional top view of reservoir  60  which may be comprised of a plastic barrier film bag and placed within the heating assembly  30  for retaining the heated water. The reservoir  60  may comprise a port or spout  34  for introducing the heated water within the interior volume  64 . Moreover, the reservoir  60  may further define a tapered edge  62  extending from the position of the port  34  to facilitate emptying of water from the reservoir  60  for storage or for re-filling of the reservoir  60  with more heated water. 
     A top view of the temperature regulation assembly  12  placed within the heating assembly  30  is shown in  FIG. 8  to illustrate how the control/indicator interface  14  may extend from the heating assembly  30  to enable the continued monitoring of its temperature during heating of the assembly temperature regulation assembly  12 . Moreover, the heated water may be introduced into the reservoir  60  through port  34 , if needed, while the temperature regulation assembly  12  is removed from or remains positioned within pouch  36 . 
     Once the temperature regulation assembly  12  is placed within bedding  16  for use with an infant, the PCM within temperature regulation element  50  may provide for warming heat for up to 8 hours or more.  FIG. 9  shows a graph  70  illustrating the temperature change over time provided by the PCM where the heat released may be maintained within a desired operating temperature range between an initial temperature of, e.g., 41° C., down to a temperature of, e.g., 35° C., over a period of several hours while maintaining a relatively constant temperature variance. 
     Turning now to the control/indicator interface  14 , the interface  14  may comprise a processor and associated electronics within which continuously monitor both the temperature of the temperature regulation assembly as well as the ambient temperature. In the event that the various temperatures are too high or too low for any reason, the interface  14  may provide a visual and/or auditory indicator or alarm to alert the user to take corrective action, if needed, such as when the temperature regulation assembly  12  is safe to use with an infant (e.g., a green light may flash with or without an auditory alarm) or when the temperature regulation assembly  12  is unsafe due to high or low temperatures (e.g., a red light may flash). The indicator  14  may be powered by an on-board power supply, e.g., batteries, or any other type of power supply. 
     The control/indicator interface  14  may also incorporate memory storage to collect and store various forms of data monitored and sensed by the system or user as well as a communication interface to transfer the data (e.g., wired or wirelessly) to or from an external device. 
     The indicator  14  may accordingly provide a number of different indications or alerts to the user. Some examples of the various indications or alerts which may be displayed or otherwise provided as shown in the chart  80  of  FIG. 10 . These indications are provided as examples and are not intended to limit the various types of indications or alerts which may be provided. 
     The indicator  14  may also be provided with one or more actuation features, such as a button, touchscreen, etc. to place the processor within the indicator within one of several available functions. A first function may silence or “snooze” any visible and/or audible alarms for about, e.g., 1.5 minutes, although this period of time may be programmed to be more or less. A second function of the indicator may be used when the assembly  12  is in use with an infant. When activated, a PCM charge indication feature may allow the user to estimate how long the assembly  12  will last so that the user may plan accordingly. Finally, a third function may initiate a demonstration mode after which the indicator  14  may revert to its normal state. 
     Because of the differences between the temperature of the assembly  12  and the variability of the ambient temperature, the processor within indicator  14  may be programmed to follow one of several different algorithms to ensure safety to the infant. An example is shown in the flow diagram of  FIG. 11  illustrating the flow between the various states of the temperature regulation assembly  12  and corresponding indications for which the indicator  14  and processor may be programmed to monitor and/or provide indications or alerts to the user. 
     The indicator  14  may be programmed to distinguish when the assembly  12  is positioned inside the receiving pouch  36  of the heating assembly  30  (e.g., when the interface attachment  38  is coupled to the indicator  14 ) as shown by the various states within block  90 . Similarly, the indicator  14  may also be programmed to distinguish when the assembly  12  is positioned outside of the heating assembly  30  such as when the unit is simply removed from the heating assembly  30  or when the unit is placed within the receiving pouch  20  of the bedding  16  for use as shown by the various states within block  92 . 
     When the assembly  12  is positioned within the heating assembly  30 , it may comply with one of several different states. For instance, prior to or during heating of the assembly  12 , the assembly  12  may be indicated as being in a COLD state  94 , e.g., by showing a red light and remaining silent, until its temperature is sensed by indicator  14  as being below 36.0° C. In the event its temperature rises to be greater than or equal to 36.5° C., indicator  14  may enter an OK TO USE state  96 , e.g., by showing a green light and alerting with a Medium Priority alarm. However, if the assembly  12  becomes overheated and unsafe for use, indicator  14  may enter an OVERHEATED state  98 , e.g., by showing a red light and alerting with a High Priority alarm (which may or may not be optionally silenced). The assembly  12  may be considered overheated if the sensed temperature is either greater than or equal to 41° C. or if the sensed temperature is greater than or equal to 38.5° C. along with a temperature rate change over time (dT/dt) of 0.2 degrees/30 seconds is also detected. However, if the temperature falls below 40.5° C. along with a temperature rate change over time of 0 degrees/minute, then the indicator  14  may revert to its OKAY TO USE state  96 . 
     Because use of the assembly  12  may be affected by the ambient temperature, the indicator  14  may also be configured to sense the ambient temperature as well and account for this variable condition. For instance, in the event that a HIGH AMBIENT state  100  is detected (e.g., when the ambient temperature is greater than or equal to 32° C.), indicator  14  may show a red light yet remain silent if the assembly  12  is still positioned within the heating assembly  30 . If the temperature of the assembly  12  is sensed to be greater than or equal to 41° C., then indicator  14  may enter the OVERHEATED state  98 . Otherwise, if the ambient temperature is less than or equal to 32° C. and the detected ambient temperature remains so for greater than 2 minutes, then the indicator  14  may enter into a COLD state  94  or OK TO USE state. The 2 minute waiting period may be programmed into the indicator  14  to ensure that any temporary temperature fluctuations are dampened and accounted for although this waiting period may be less than or greater than 2 minutes or may be omitted entirely if so desired. 
     In the event that the temperature regulation assembly  12  has been removed from the heating assembly  30 . e.g., for use within bedding  16 , then the indicator  14  may indicate or alert any one of the states shown in block  92 . For instance, in the event that a temperature of the assembly is less than 35° C., a COLD state  102  may be indicated, e.g., by showing a red light and indicating a High Priority alarm, to alert the user that the assembly  12  requires heating and should not be used with an infant. 
     However, if the assembly  12  is sensed to fall below 35.3° C. during its use, then an EARLY HEATING INDICATION state  104  may be indicated, e.g., by showing a green light and alerting with an optional repeating alert or alarm, to alert the user that the assembly  12  may need to be re-heated within a predetermined period of time, e.g., within 30 minutes, to allow the user to make preparations accordingly such as by heating water for the heating assembly  30 . If the assembly  12  is sensed to further fall below 35.0° C., then it may re-enter the COLD state  102 ; otherwise, if the assembly  12  is sensed to rise to be greater than or equal to 36° C. then the indicator  14  may enter an OK TO USE state  106 . However, in the event that the assembly  12  is sensed to rise in temperature to be greater than or equal to 41° C., then the indicator  14  may enter an OVERHEATED state  108 , e.g., by showing a red light and alerting with a High Priority alarm, to alert the user that the assembly  12  should not be used with the infant and should be allowed to cool before use. If the indicator  14  senses that the temperature has fallen below 38.5° C., then the indicator  14  may enter back into its OK TO USE state  106 . 
     As described above, because use of the assembly  12  may be affected by the ambient temperature as sensed by the indicator  14 , an additional state may be accounted for as shown by the HIGH AMBIENT state  110 . In the event that an ambient temperature of greater than or equal to 32° C. is detected over a waiting period of, e.g., 2 minutes, is sensed, then the indicator  14  may enter the HIGH AMBIENT state  110  from either its COLD state  102 , EARLY HEATING INDICATION state  104 , or from its OK TO USE state  106 , e.g., by showing a red light and alerting a High Priority alarm, as an indication to the user that use of the assembly  12  may not be needed due to the already high ambient temperature. Otherwise, if the ambient temperature is sensed to be equal to or less than 32° C. over a period of, e.g., 2 minutes, then the indicator  14  may enter back into its COLD state  102 . However, if the temperature of the assembly  12  is further sensed to be equal to or greater than 41° C., then the indicator  14  may further enter its OVERHEATED state  108  to further alert the user that either the assembly  12  may need to be first cooled and/or until the ambient temperature falls sufficiently. 
     With the various states (when the assembly  12  is either within the heating assembly  30  or outside the heating assembly  30 ),  FIG. 12  shows the flow diagram of  FIG. 11  but with indications of when the temperature regulation assembly  12  may be re-positioned between the heating assembly  30  and bedding  16  (or simply removed from the beating assembly  30 ). For instance, when the indicator  14  shows the assembly  12  as being in a COLD state  94  or  102 , the assembly  12  may be re-positioned between the heating assembly  30  or removed from the heating assembly  30 . Similarly, if the indicator  14  shows assembly  12  as being in its EARLY HEATING INDICATION state  104 , assembly  12  may be re-positioned into the heating assembly  30  where it may enter its COLD state  94  for further heating. 
     In the event that the indicator  14  shows that the assembly  12  is OKAY TO USE  96  within the heating assembly  30  or OKAY TO USE  106  when removed from the heating assembly  30 , the assembly  12  may be re-positioned between either state. Similarly, in the event that the indicator  14  shows that the assembly  12  is OVERHEATED  98  within the heating assembly  30  or OVERHEATED  108  when removed from the heating assembly  30 , the assembly  12  may be re-positioned between either state for cooling. Likewise, if a HIGH AMBIENT state  100  is indicated within the heating assembly  30  or HIGH AMBIENT state  110  when removed from the heating assembly  30 , the assembly  12  may be re-positioned between either state until the ambient temperature falls. 
     Additionally and/or alternatively, the system may also incorporate a number of features to further provide for the safety and comfort of the infant placed within the system. For instance, the control/interface unit  14  may alert to conditions such as the ambient temperature being too low or too high or it may automatically trigger other actions that ensure usage of the device when in a safe ambient temperature range. Moreover, the system may also incorporate one or several monitoring peripherals  120  to monitor various physiological parameters of the infant (e.g., vital parameters such as infant temperature, weight, oxygen levels, respiration, heart rate, etc.).  FIG. 13  shows an example of an infant IF placed upon the bedding  16  of the system. A monitoring peripheral  120 , which may be configured to sense any number of the physiological parameters of the infant IF, may be attached either directly upon or in proximity to the infant IF. Moreover, the monitoring peripheral  120  may be optionally coupled to the control/interface unit  14  (e.g., via a wire  122  or wirelessly) to transmit the physiological data to the control/interface unit  14  where the processor may utilize this information for monitoring or for storing the data to memory. Alternatively, the peripheral  120  may instead be in communication with an extemal unit. 
     Additionally, one or more monitoring and/or peripheral devices  124 , e.g., air-purifiers, may be used in combination with the system and optionally connected to the control/indicator interface  14  (e.g., wired or wirelessly), as shown in  FIG. 14 . Such devices  124  may be used to control or create a local environment or microclimate around or in proximity to the infant such as creating or maintaining hygienic levels of air quality (in one example) around the infant IF. Other devices may be used in other examples such as ambient warmers, humidity controllers, etc. Such monitoring peripherals  120  as well as monitoring and/or peripheral devices  124  may be used in any number of combinations with any of the variations described herein. 
     While illustrative examples are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein. Moreover, various apparatus or procedures described above are also intended to be utilized in combination with one another, as practicable. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.