Abstract:
A heating device for individually and automatically warming and vibrating one or more containers to thaw, warm, and mix a liquid within the containers, the liquid being cold or frozen. The device heats the contents of each container to a selected temperature by heat exchange between a heated fluid and the contents of the container. A bag or liner holds the fluid to be heated and the container thereby allowing the bag or liner to be placed into a device well or reservoir for heating while vibrating or shaking elements connected to the well or reservoir assist in mixing and uniformly heating the fluid and the container contents. The container typically is a baby bottle, syringe, test tube, or the like.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims priority under 35 U.S.C. 119(e) and 37 C.F.R. 1.78(a)(4) based upon copending U.S. patent application Ser. No. 11/801,142 for Neonatal Nutrition Warmer filed May 9, 2007 and to copending U.S. Provisional Application Ser. No. 60/851,936 for Warmer and Cooler for Bottled Liquid filed Oct. 16, 2006. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to devices for heating fluids, in particular, the present invention provides transmission of heat and vibration to a first fluid for even transmission of heat to a nutritional solution for neonates. In particular, the invention relates to a novel heating device and heat transfer fluid container for warming neonate nutrition, for example, breast milk in a quick, reliable and automated manner. More particularly, the embodiments of the device provide a means, generally in the form of a bag-like container, for maintaining security over the nutritional solution during storage and warming and other preparation procedures and for isolating the nutritional solution from contaminates during storing and warming and preparing of the solution and for keeping isolated from the warming device the fluid used to disperse and make uniform the application of heat to the nutritional solution. Several collar embodiments are provided to maintain separation of the nutrition-holding container from the heat transmission fluid to thereby avoid contamination of the container opening by avoiding it contacting the heat transmission fluid.  
       BACKGROUND OF THE INVENTION  
       [0003]     In general, devices for warming fluid containers have been used extensively in the prior art. Until the development of the device shown in U.S. Pat. No. 6,417,4987 (incorporated herein by reference) no suitable devices have been available for use in warming baby bottles in neonatal intensive care units (NICU) of a hospital. NICU are responsible, among many other things, for administering substrate, formula, or breast milk to newborn infants. Medical studies reinforce the fact that newborns benefit significantly from receiving colostrum—the first milk of the mother after giving birth. Colostrum is known to supply extremely high concentrations of antibodies essential to the development of a newborn&#39;s immune system, and is also thought to aid in establishing digestion of the newborn. Accordingly, it is absolutely critical to capture the colostrum from the mother and carefully preserve it for later administration to the newborn as quickly, cleanly, and safely as possible.  
         [0004]     In current practice, NICU nurses capture breast milk from the mother in baby bottles, refrigerate or freeze the breast milk, rewarm the breast milk, and feed it to the newborn. Newborns tend to feed about eight times per day, which necessitates frequent thawing, warming, and administering of breast milk. This frequent and time consuming process wastes an enormous amount of time for the NICU nurses, especially due to the manually intensive method of thawing and warming the breast milk. Using a microwave to warm the breast milk is not a viable option since such a process has a detrimental effect on the quality of the breast milk.  
         [0005]     Instead, the breast milk is thawed and warmed by placing the baby bottle into a large insulated cup full of hot tap water. Due to simple heat transfer principles, the hot water quickly cools down even before the breast milk has had a chance to thaw, much less warm up to body temperature. Therefore, NICU nurses must repeatedly add hot water to the insulated cup in order to thaw and warm the breast milk. As such, NICU nurses waste precious time maintaining an archaic warming process instead of attending to newborns. In the alternative, NICU nurses sometimes leave the insulated cup and baby bottle under a faucet of running hot water. Unfortunately, this approach works, for only one bottle at a time and, if left unattended, results in a temporary depletion of hot water supply or possibly overheated breast milk.  
         [0006]     There are other problems with the insulated cup warming process. For one, since the method is entirely manual and subjective, it is possible that the temperature of the breast milk is inadequately warmed and is either too cold or too hot. Additionally, it is important that the bottle be shaken to agitate and properly mix the breast milk; however, because of the often hurried pace of an NICU and the manual nature of the warming process the baby bottles are not always adequately shaken. Finally, the current warming process results in a mess of half full insulated cups lying about on NICU counter tops that often times are inadvertently knocked over, creating an even bigger mess and an aura of untidiness.  
         [0007]     The prior art has suggested use of heated bath immersion devices. For example, one complicated apparatus in effect accomplishes the same result as the insulated cup/running tap water process mentioned above. U.S. Pat. No. 4,597,435 to Fosco, Jr. teaches a bottle warmer that uses a thermal transfer fluid to heat a baby feeding bottle. Fosco, Jr. discloses a portable device having an open top cup-like container for holding hot water therein. A removable platform is positioned within the container for suspending a baby bottle inside the container in contact with the hot water. The removable platform separates the container into an upper and lower chamber. An open-ended tube extends from the top of the container down into the lower chamber for conveying incoming tap water thereto. Accordingly, the portable device is placed under a faucet dispensing running hot water such that the hot water is directed down into the open-ended tube. The hot water thus enters the lower chamber and is forced under pressure up around the sides of the suspended baby bottle and into the upper chamber until it exits via the open top of the container. Obviously, the Fosco, Jr. warmer provides an unnecessarily complex apparatus for bottle warming that, in effect, is substantially similar to the insulated cup method that NICU nurses currently use. Therefore, Fosco, Jr. does not address, much less solve, the above-mentioned problems. Furthermore, the background section of Fosco, Jr. discusses the shortcomings of several other receptacle-type devices that need not be further explored here.  
         [0008]     Additionally, the prior art has suggested use of dry block heaters for heating test tubes. Dry block designs typically use metal blocks having a central or localized heating passage therethrough. A series of tube wells are typically arranged in a pattern within the metal block in close proximity to the heating passage. Heat flowing through the heating passage transfers through the block, into the tube wells, and into test tubes placed in the tube wells. This design has one significant drawback in particular. The tube wells are of a necessarily fixed diameter to accept a slightly undersized test tube, thereby establishing a close fitting relationship between the metal block and test tubes to enable effective heat transfer therebetween. Unfortunately, this configuration is not flexible enough to permit use of a variety of sizes of test tubes with a particular block. Therefore, only one size of test tube, or baby bottle, could be used with such a device. Since different NICU inevitably use bottles from different manufacturers that are of different sizes and shapes, this type of fixed block design is not practical for the purposes intended according to the present invention.  
         [0009]     With respect to the device shown in U.S. Pat. No. 6,417,498 a drawback is found even in this advance device. The repeated use of the same heat transferring fluid in the wells of the device can lead to bacterial growth in the wells and in the heat transferring fluid. When such bacterial growth takes place it is ill-advised to insert the neonate formula container therein as this would assist in the transmission of bacteria to mother and child. The options is to constantly change heat transferring fluid and/or to repeated clean the wells and the surface of the device during use. Such a cleaning regimen is inconvenient in a busy hospital and can be neglected. Therefore it would be a benefit if a means were available of isolating the heat transferring fluid from the wells and of isolating the heat transferring fluid from the opening of the neonate formula container. It would be a further benefit if such a means avoided repeated emptying and filling of the heat transmitting fluid and permitted the neonate formula container to be secured from tampering during the storage and warming stages of use.  
         [0010]     From the above, it can be appreciated that baby bottle warming methods and apparatus of the prior art are not fully optimized. Therefore, what is needed is an automatic bottle-heating device that quickly, accurately, individually, and simultaneously warms and vibrates a multitude of baby bottles so as to adequately heat and mix breast milk contained therein.  
       SUMMARY OF THE INVENTION  
       [0011]     A warming device for thawing and heating neonate nutrition is provided which has an individual heater unit and individual vibrator unit connected to one or a plurality of wells. The wells receive a flexible bag therein the bag containing a heat transmitting fluid and a container of neonate nutrition—usually breast milk. The wells are heated and vibrated to warm the heat transmitting fluid and the wells are shaken to circulate the heat transmitting fluid to provide even heating and even transmission of heat to the neonate nutrition. The vibrating further circulates the neonate nutrition to distribute the transmitted heat within the neonate nutrition. A collar may be provided for positioning around the container holding the neonate nutrition. The collar maintains the container opening and/or the container closure in a spaced relation above the heat transmitting fluid which also is within the flexible bag. The collar may maintain the spaced relationship between the heat transmitting fluid and the container closure or container opening by providing buoyancy to the container or by the collar contacting the sidewall of the warming device well to thereby be supported by the well and to maintain the container closure and/or container opening above the surface of the heat transmitting fluid.  
         [0012]     The foregoing is intended to be illustrative of the invention and is not meant in a limiting sense. Many possible embodiments of the invention may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. Various features and subcombinations of invention may be employed without reference to other features and subcombinations. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, an embodiment of this invention. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0013]     Preferred embodiments of the invention, illustrative of the best modes in which the 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.  
         [0014]      FIG. 1  shows a front and left side and top perspective view of an embodiment having four warming wells with bags containing heat transmitting fluid and containers of neonate nutrition situated therein;  
         [0015]      FIG. 2  is an exploded and partial fragmentary view of the embodiment of  FIG. 1 , and showing a void in the housing to receive the well;  
         [0016]      FIG. 3  is a fragmentary rear left side and top perspective view of the embodiment of  FIG. 1 ;  
         [0017]      FIG. 4  shows an embodiment of a bag for holding heat transmitting fluid with a nutrition container suspended within the bag and heat transmitting fluid by a collar fitted about the container to maintain the container closure in spaced relation above the heat transmitting fluid contained within the bag;  
         [0018]      FIG. 5  shows an alternative embodiment of a collar providing similar function to the collar of  FIG. 4  and showing the collar of  FIG. 5  provided with stand-offs for engaging the sidewalls of the well and with a fold line included in the collar to allow collapsing of the collar within the bag when not in use in holding a container;  
         [0019]      FIG. 6  shows yet another alternative embodiment of a collar of the type of embodiments as described in  FIGS. 4 and 5 ;  
         [0020]      FIG. 7  shows the collar of  FIG. 6  having a neonate formula bottle inserted therein;  
         [0021]      FIG. 8  shows the use of the collar of the embodiment of  FIG. 6  to support a syringe-type feeding device for neonates to allow warming of the nutritional material within the syringe while maintaining the plunger end of the syringe spaced above the heat transmitting fluid contained within the bag;  
         [0022]      FIG. 9  shows an alternative embodiment of bag  16  in which welds  92   a,b  spot-weld together bag front wall  96   a  to bag rear wall  96   b  to provide a stricture within the bag to capture and retain cap  74  between welds  92   a,b  when container  18  is inserted into bag  16  and passed between welds  92   a,b  resulting in capture of closure  74  by the stricture created by welds  92   a,b;    
         [0023]      FIG. 10  is a cross-section view taken along line  10 - 10  of  FIG. 9  and showing the creation of the stricture by welds  92   a,b  for capture of closure  74  there between;  
         [0024]      FIG. 11  is a side elevation view showing an alternate mounting of the securing frame by a screw  42  seated into a tubular support  44 ;  
         [0025]      FIG. 12  shows an alternate structure for heating and cooling well  14   a - 14   d  using a peltier thermoelectric module to provide both heating and cooling of the liquid in well  14   a - 14   d;    
         [0026]      FIG. 13  shows an embodiment in which a radio frequency identification device having a temperature sensor therein is within the container holding the breast milk or formula;  
         [0027]      FIG. 14  shows and embodiment in which an infrared detector is provided for direct temperature readings of the temperature of the breast milk or formula;  
         [0028]      FIG. 15  shows and alternate embodiment having an infrared detector for direct temperature readings of the temperature of the breast milk or formula;  
         [0029]      FIG. 16  shows an embodiment of a portable warmer pouch that can be wrapped about a container or syringe containing the breast milk or formula;  
         [0030]      FIG. 17  shows the warmer pouch of  FIG. 16  wrapped about a syringe; and  
         [0031]      FIG. 18  shows the warmer pouch of  FIG. 16  wrapped about a syringe that is mounted in a metered feeding device.  
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0032]     As required, detailed embodiments of the present inventions are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.  
         [0033]     Referring to  FIG. 1 , an embodiment of the warming device  10  is shown comprising a housing  12  which generally supports a plurality of wells or reservoirs  14   a - 14   d  into which may be placed reservoir bags or liners  16 . Reservoir bags  16  are utilized to generally hold a container  18  which is filled with a liquid neonate nutritional substance, such as breast milk, that is in need of thawing or warming to a temperature for use. It will be appreciated by those skilled in the art that while a flexible bag is used in the preferred embodiment, that a rigid liner of plastic or other heat transferring material could be used to isolate the heat transfer fluid  58  from the well  14 . In general operation, a container  18  having neonate formula or breast milk therein is placed within bag  16  with a heat transfer fluid which previously has been placed into bag  16 . Bag  16  is then introduced into well  14  of housing  12  of warming device  10  and heating and/or vibrating or shaking of the well  14  is commenced to achieve warming of the neonate formula or nutritional liquid which is in container  18  within bag  16 . With this general description of the operation of the present invention in mind, warming device  10  and bag  16  will be described in greater detail hereinafter.  
         [0034]     Still referring to  FIG. 1 , it may be appreciated that housing  12  is provided with opposed handles  20  (right side handle not shown) and individual control panels  22   a - 22   d  which are used to individually control wells or reservoirs  14 A- 14 D. Referring now to the control panel  22   d  as being representative of control panels  22   a - 22   d , the specifics of each control panel will be described with reference thereto. In control panel  22   d , a data display  24  is provided which may display various information regarding the fluid substance within container  18  that is retained within well  14   d . For example, the name of the mother and/or child for whom the neonate formula is intended may be displayed on data display  24  as well as a room number or social security number or other identifying information such as an indicia  26  which is used to identify each individual bag  16  and associate each individual bag  16  uniquely with a particular patient or child. Control panel  22   d  also includes a computer controlled temperature readout display  28  and light emitting diodes (LEDs)  30  to indicate the heating status of the device. As it is beneficial to shake or vibrate each individual well  14  as it is being used to better achieve consistent warming of the heat transmitting fluid and the nutritional formula within container  18 , an on/off control  32  for the vibration unit associated with each well  14   a - 14   d  also is provided on data display  24 . As each of wells of  14   a - 14   d  are independently operable, a separate on/off switch  34  is provided to allow for individual control of each of wells  14   a - 14   d.    
         [0035]     Referring now to  FIG. 2 , the individual components comprising warmer device  10  and, in particular, each of wells  14   a - 14   d  will be described. In the exploded view of  FIG. 2 , reservoir or well  14   a  has been separated into its component parts. Housing  12  of warming device  10  on its upper surface  36  is provided with a plurality of voids  38   a - 38   d  into which well  14   a  and its associated components are seated. A securing frame  40  is seated within void  38   a  with the base of securing frame  40  being attached by a screw  42  to support  44 . A shaking or vibrator device  46  is connected to securing frame  40  to provide individually controllable shaking or vibrating of well  14   a . Dampening cuff  48  is press fitted and clamped against the rim which defines void  38   a  in upper surface  36  and stiffening gasket  50  is fitted on dampening cuff  48  to assist in retaining dampening cuff  48  in position on housing  12 . Heating unit or heating blanket  52  is positioned about or wrapped about well  14   a  and heating unit or blanket  52  and reservoir or well  14   a  is inserted by press fitting heating blanket  52  and well  14   a  into dampening cuff  48 . Once well  14   a  has been inserted into dampening cuff  48 , well  14   a  may be held in securing frame  40  by compression band  54  which is reduced about securing frame  40  and well  14   a  using worm gear  56 . This connection between securing frame  40  and well  14   a  assists in the transmission of shaking or vibration from vibrator  46  to provide shaking or movement or mixing of the heat transfer fluid  58  which is contained within bag  16 . It will be appreciated that heating unit or heating blanket  52  is provided with power leads  60  which are connected to the power supply (not shown) of device  10 . For operation, bag  16  is inserted into well  14   a  and container  18  and heat transfer fluid  58  are added to bag  16  for transmission of heat from well  14   a  through heat transfer fluid  58  to the contents of container  18 .  
         [0036]     Referring now to  FIG. 3 , power is provided to warming device  10  by power cord  62  which enters housing  12  at rear wall  64 . Adjacent power cord  62  is data port  66  which may be a USB port or other convenient type of data port which can be used to transfer information to/from data display  24  and/or to allow the recording of data related to the operational status of each of wells  14   a - 14   d.    
         [0037]     Referring now to  FIGS. 4 and 5 , the use and operation and structural components of bag  16  will be described in more detail. Bag  16  is used to hold and separate a heat transfer fluid  58  from contact with reservoir or well  14   a - 14   d . Prior devices have relied upon the heat transfer fluid being placed directly into well  14   a - 14   d  thus creating a cleaning and sanitary problem within hospitals and nurseries and the like. The use of bag  16  to hold and separate heat transfer fluid  58  from reservoir or well  14   a - 14   d  provides the benefit of cleanliness and sanitation which is not achieved by prior art devices. It will be appreciated by those skilled in the art that many liquids, or even heat transmissible solids or particulate solids, could be used to transfer the heat generated by heating unit or heating blanket  52  to well  14   a  and across and into container  18  holding the neonate nutrition. By way of example and not limitation, it will be appreciated that heat transfer fluid  58 , referred to in the embodiments described herein, could be replaced by various aqueous solutions, or by an appropriate oil such as mineral oil or silicon oil or that a heat transmitting solid such as sand or sodium chloride could be substituted for heat transfer fluid  58 . The only object being that the heat generated by heating unit  52  be swiftly and consistently transferred into the contents of container  18 . To this end, it, of course, will be appreciated, that a transfer fluid as opposed to a transfer solid or semi-solid is most easily used for such a situation and an inexpensive fluid, such as water, is likely the fluid of choice.  
         [0038]     Still referring to  FIGS. 4 and 5 , bag  16  may be made from any pliable or flexible plastic the specifics of which are well known to those skilled in the art. Polyethylene bags, for example, may be used for bag  16 . The bag of the embodiment shown in  FIG. 4  is provided with a generally tapered or frusto-conical sidewall shaping. It will be appreciated that reservoir or well  14   a  of one embodiment described herein is provided with a similar conical or frusto-conical tapering of the sidewalls  68  ( FIG. 2 ) of wells  14   a - 14   d , and that a similar tapering is provided to the continuous sidewall  70  of bag  16 . The tapering of sidewall  70  of bag  16  to generally match the tapering of sidewall  68  of well  14   a  allows for close contact between bag  16  and well  14   a  thereby enabling efficient transfer of heat from well  14  to heat transfer fluid  58 .  
         [0039]     Examination of bag  16  of  FIGS. 4 and 5  shows that two different embodiments of a collar  72  are shown in  FIGS. 4 and 5 . A third collar embodiment is shown in  FIGS. 6, 7  and  8 . While various collar embodiments are shown in  FIGS. 4-8 , the operation of collar  72   a  ( FIG. 4 ) and collar  72   b  ( FIG. 5 ) and collar  72   c  ( FIG. 6 ) are similar. In operation, the collar embodiments  72   a ,  72   b  and  72   c  operate to hold or suspend container  18  within heat transfer fluid  58  which is held within bag  16 . Collar  72  is provided to maintain closure  74 , which covers the opening into container  18 , spaced above the surface of heat transfer fluid  58  to thereby avoid any contact of closure  74  or the opening of container  18  with heat transfer fluid  58  while container  18  is within bag  16  and in contact with heat transfer fluid  58 . This separation of closure  74  and the opening of container  18  from heat transfer fluid  58  is desirable for sanitary reasons. The spacing ensures that non-sterile and possibly contaminated fluids do not come into contact with surfaces which may be contacted by the mouth of the neonate. The construction of collar  72   a ,  72   b  and  72   c  may be such that container  18  is allowed to float on the surface of heat transfer fluid  58  where the weight of the contents of container  18  allows for buoyancy. But it is a principle feature of collar of  72   a ,  72   b  and  72   c  that the collar contact sidewall  68  of reservoir or well  14   a - 14   d  in a frictional fit manner so collar  72  is supported by sidewall  68  of wells  14   a - d  to maintain closure  74  of container  18  and the opening into container  18  spaced above the surface of heat transfer fluid  58  when bag  16  having fluid  58  and container  18  therein is inserted into well  14 . Collar  72   a  ( FIG. 4 ) is provided with a generally smooth outer perimeter  76  which is sized to seat within well  14   a  and to contact sidewall  68  of well  14   a  to support container  18  and closure  74  above the surface of heat transfer fluid  58 . It will be appreciated that where container  18  and its contents are sufficiently buoyant within heat transfer fluid  58  that collar  72   a ,  72   b  and  72   c  will serve to provide a stabilizing aspect to container  18  as it floats in heat transfer fluid  58  and thereby preventing tilting of container  18  which might bring closure  74  or the opening of container  18  into contact with heat transfer fluid  58 .  
         [0040]     Referring now to  FIG. 5 , collar  72   b  is shown inserted and welded within bag  16 . Collar  72   b  is an embodiment having standoff flanges or welding flanges  78  extending from outer perimeter  76  of collar  72   b . Flanges  78  are attached, by welding in a preferred embodiment, to sidewall  68  of well  14   a - 14   d  to provide support to container  18  held within collar  72   b . Flanges  78  connect collar  72   b  to bag  16  while avoiding complete securing of outer perimeter  76  with bag  16  as this would inhibit the folding flat of the bag and collar assembly. A fold line  80  is provided in collar  72   b  which permits collar  72   b  to be folded in half thereby allowing for the complete collapsing of bag  16  for shipment and storage when heat transfer fluid  58  is not within bag  16 . It will be appreciated by those skilled in the art that bag  16  is provided with a convenient seal mechanism, such as the sliding zipper-type closure  82  ( FIG. 5 ), though any convenient means of sealing bag  16  may be used. It will also be appreciated that an adhesive seal may be preferred thereby providing a means of security to bag  16  which would evidence the improper opening of bag  16  by an unauthorized person after it has been properly sealed by neonate caregivers. An identifying indicia, such as bar code  26 , also may be included on bag  16  to provide specific and/or unique identification of bag  16  and to associate bag  16  and its contents with a particular patient or neonate. A second indicia  84 , which also may be a bar code, may be included on container  18  for separate tracking of container  18 .  
         [0041]     Referring now to  FIGS. 6, 7  and  8 , another embodiment of the collar  72  used to support container  18  within bag  16  is shown. Collar  72   c  of  FIG. 6  is comprised of a disc having a plurality of voids therein and with a portion of the interstitial material between the voids removed to create flaps  88 . As shown in  FIG. 7 , flaps  88  are flexible and allow the insertion of variously sized objects, such as container  18  ( FIG. 7 ), and/or feeding syringe  90  ( FIG. 8 ) into collar  72   c . It will be appreciated by those skilled in the art that collar  72   c  is most beneficially made from a flexible plastic or rubber, such as neoprene or polyethylene or polypropylene which is selected to provide a sufficient degree of flexibility so that variously sized objects may be supported within collar  72   c  by flaps  88 . In this manner, variously sized devices may be supported by collar  72   c , as well as oddly or asymmetrically shaped devices. It should further be appreciated that the materials for a construction of collar  72   a  and/or  72   b  may be less flexible than the most desirable materials used to construct collar  72   c  By contrast, collar  72   a  and  72   b  do not require the degree of flexibility which is desirable for flaps  88  of collar  72   c , rather, collars  72   a ,  72   b  may be of a more rigid nature as they are generally designed to accommodate the particular container size  18  being employed by the user of device  10 .  
         [0042]     Referring now to  FIG. 9 , another embodiment of bag  16  is shown in which closure  74  is retained above the surface of fluid  58  by the inclusion of a restriction in the opening provided within bag  16 . The restriction or stricture is formed within the interior of bag  16  by spot-welding together first and second welds or weld areas  92   a ,  92   b  of front wall  96   a  ( FIG. 10 ) to rear wall  96   b  ( FIG. 10 ) of bag  16 . It is important that the welds  92   a ,  92   b  be sufficiently spaced apart to allow container  18  to be inserted between welds  92   a ,  92   b , but sufficiently closely spaced to capture closure  74  on container  18  to thereby capture container  18  and retain closure  74  spaced from heat transmitting fluid  58 . Therefore, it will be appreciated that to achieve this configuration that welds  92   a ,  92   b  are positioned as to be bilaterally spaced apart, generally, from the vertical center of bag  16  and the welds are sufficiently spaced above the bottom of bag  16  to allow closure  74  to be above the heat transmitting fluid  58  when the closure is captured between welds  92   a ,  92   b.    
         [0043]     The bag shown in  FIGS. 9 and 10  is comprised of a typical plastic bag which typically is made of polyethylene or other appropriate flexible material and which has a front wall  96   a  sealed to a rear wall  96   b  at edges  94  to form a bag interior for holding contents therein. The top portion of bag  16  is closed by a zipper-type closure  82  which is well-known in the art. The embodiment of  FIG. 9  is adapted to retain closure  74  with container  18  above the surface of fluid  58  which has been introduced into bag  16  to provide a heat transfer medium for warming of a nutritional solution which is within container  18 . As previously remarked, it is preferred to maintain the opening of container  18 , as well as closure  74  spaced above heat transfer fluid  58  for sanitary purposes. The embodiment of  FIG. 9  accomplishes this by inclusion of weld points  92   a ,  92   b  which serve to hold together or connect a portion of front wall  96   a  to a portion of rear wall  96   b  to create an open area  98  therebetween. Open area  98 , which constitutes the opening between weld  92   a  and weld  92   b , is of a reduced diameter as compared to the overall diameter of bag  16  and it is, in general, of sufficient size to permit the passage of container  18  there through while restricting the passage of closure  74  there through. In this manner, when bag  16  is supported in an upright fashion, either by a user grasping the upper edge of bag  16  adjacent to closure  82 , or by inserting bag  16  into any of wells  14   a - 14   d , closure  74  is maintained spaced from fluid  58  and contamination of closure  74  and the opening of container  18  (not shown) is avoided.  
         [0044]     In  FIG. 10 , a cross-section view, taken along line  10 - 10  of  FIG. 9 , shows the constriction of bag  16  at welds  92   a ,  92   b  which serves to prevent the passage of closure  74  past the welds  92   a ,  92   b  while allowing the container  18  to pass downwardly between the welds and into the heat transmitting fluid  58 .  
         [0045]     Referring now to  FIG. 11 , an alternate mounting of well  14   a - 14   d  is shown wherein a screw or post  42  extending from securing frame  40  extends into a tube acting as support  44 . The tube-type support functions to restrict the side-to-side movement of frame  40  during the operation of vibration device  46 .  
         [0046]     In  FIG. 12  and alternate device for heating and cooling well  14   a - 14   d  is shown. A peltier thermoelectric module  100  operating on 12 volts direct current is mounted in contact with well  14   a - 14   d . Peltier modules are semi-conductor elements which allow cooling, heating and temperature regulation through direct current electricity. By putting a direct current through a peltier module, a temperature difference develops on the sides of the unit. The low temperature side absorbs heat, and the high temperature side radiates heat, transferring heat from the low to the high temperature side of the peltier module. By changing the polarity of the current, the direction of heat flow can be changed. Also, by altering the size of the current it is possible to change the amount of heat transfer. By connecting a peltier module  100  to a metallic well  14   a - 14   d  a single structure can be used to heat and cool the contents of well  14   a - 14   d . It will be appreciated by those skilled that the peltier module  100 , which is described above as a block that is mounted in contact with well  14   a - 14   d , could be constructed as the well  14   a - 14   d  itself. In this embodiment the well  14   a - 14   d  is actually constructed as a peltier module  100  and therefore the heating and cooling of heat transfer fluid or material  58  can be accomplished by the well  14   a - 14   d  which is capable of producing heating or cooling itself.  
       Formula Direct Temperature Detection  
       [0047]     One drawback of the previous systems for formula warming is the accurate determination of temperature-warming endpoints and temperature monitoring generally. This is a result of the indirect determination of the actual temperature of the breast milk or formula. In previous systems temperature determination often has been based on assumptions and the timing of applied heating based on the generalized starting point temperature of the breast milk or formula (i.e., frozen or room-temperature starting temperature of the breast milk or formula). This drawback is overcome by one of the several embodiments for making direct temperature measurement of the breast milk or formula described below. In general, these embodiments employ the use of direct temperature measurement by infrared temperature detection of the temperature of the breast milk or formula. Alternatively, the direct temperature measurement of the breast milk or formula can be achieved by inclusion of a radio frequency reporting temperature sensor within the breast milk or formula such as a radio frequency identification device (RFID) having a temperature tracking or monitoring capability.  
         [0048]     Referring to  FIG. 13 , a radio frequency identification device (RFID)  130  having a temperature tracking or monitoring capability is shown included within the breast milk or formula in container  18 . The RFID device can be used to repeatedly detect the temperature of the breast milk or formula as the temperature of the breast milk or formula is increased or held static by the warmer device  10  ( FIG. 1 ) or during storage in a refrigerator or during transport between the storage area and the warmer or the warmer and the neonate or mother prefatory to feeding.  
         [0049]     One such RFID tag or RFID device  130  for inclusion with the breast milk or formula or for attachment to the wall of the container  18  is the Log-ice Temperature Tracker which is produced by Intelligent Devices, Inc., of Suwanee, Ga. The Log-ic device allows temperature monitoring over time and weighs less than 1 oz. The size of the Log-ic device is approximately 2 inches square with a thickness of about 0.1 inches. The Log-ic is a flexible RFID sensor tag capable of processing up to 64,000 temperature readings. It can be calibrated for a temperature sensitivity of from ±0.1 to ±1° Celsius. The device is available both as single use disposable device as well as re-usable versions.  
         [0050]     The Log-ic® tag can be programmed and its data collected by use of a CertiScan® wireless 13.56 MHz RFID solution also available from Intelligent Devices, Inc. A handheld data collection device can be used to monitor tags  130  on containers  18  as they are found in the neonate ward in various locations such as in the freezer or refrigerator or in the warmers on a transport cart or within the neonate nursery. The tags  130  can be kept in inventory in a power conserving “sleep” mode until they are required for use. The tag  130  is activated by pushing a button on the tag to begin the temperature monitoring of the contents of the container  18 .  
         [0051]     The tags  130  are capable of receiving programmable temperature thresholds via two-way radio frequency communication. The tag  130  can be programmed so that should a temperature fault occur during the handling of the breast milk or formula (for example, a temperature that is out of the acceptable temperature range is reached for a time greater than 5 minutes) the tag is programmed to display a warning light to the end user that a temperature fault condition was reached.  
         [0052]     The tags  130  do not have to be removed from the container  18  to capture their data. This saves time and maintains the ability to keep the breast milk or formula isolated within the container  18  until use. The tag data can be constantly downloaded via the wireless CertiScan RFID reader during the entire time the breast milk is being held in container  18  to ensure that proper temperature and handling always is maintained. Since the tag  130  can perform up to 64,000 readings the quality and safety of the breast milk can be tracked, verified and documented without active human contact with the breast milk or formula.  
       Direct Temperature Detection Via Infrared Radiation Pyroelectric Sensors  
       [0053]     Referring now to  FIGS. 14 and 15  two embodiments of an infrared radiation (IR) pyroelectric sensor are shown for direct measurement of the temperature of the neonate formula or breast milk contained in the container  18 . The pyroelectric sensor is used to detect infrared radiation that is emitted by the neonate formula or breast milk as it is warmed in the container  18 . Such sensors are known to those skilled in the art.  
         [0054]     In general, pyroelectric sensors are made of a crystalline material that generates a surface electric charge when exposed to heat in the form of infrared radiation. When the amount of radiation striking the crystal changes, the amount of charge also changes and can then be measured by a field-effect transistor (FET) sensor. Pyroelectric sensors can be made from lithium tantalate (LiTaO3) which generates electric charges with small temperature changes. These sensors are small, stable, uniform and durable and thus well suited to a high use environment such as a hospital.  
         [0055]     In the embodiment of  FIG. 14 , the IR sensor  140  is suspended over the container  18 . The top or cap of container  18  has been constructed from an infrared transparent material so as not to interfere with temperature reading. A telescoping and rotateable arm  142  mounted in holder  144  is used to suspend the IR sensor  140  over the container  18  and can be used to rotate sensor  140  out of the way when the container  18  is inserted into or removed from the warmer  10 .  
         [0056]     In the embodiment of  FIG. 15 , the IR sensor  150  is inserted into the bottom of each well  14 . In this manner the IR sensor  150  makes direct contact with bag  16  and the container  18  inside the bag as both are suspended in well  14 . In this manner detection of the temperature of the heat transfer fluid  58  is avoided. An infrared detector suitable for this purpose is sold by Raytek Corporation of Santa Cruiz, Calif. The Raytek model CI1A having a J thermocouple output has an overall temperature detection range of 0° C. to 115° C. (32° F. to 240° F.). As can be appreciated by examination of  FIG. 15 , infrared sensor  150  extends upwardly into well  14  and the bottom of bag  16  and the bottom of container  18  contact sensor  150 . This direct contact is intended to exclude heat transfer fluid  58  so that the temperature of heat transfer fluid  58  does not affect the reading obtained by sensor  150 . It also will be appreciated that the material used to construct the bottom of container  18  must be infrared transparent to properly permit sensor  150  to detect the infrared radiation being emitted by the breast milk or formula within container  18  as it is warmed by heat transfer fluid  58 .  
         [0057]     Thus, in the operation of the embodiments of  FIGS. 14 and 15 , the infrared detector or sensor  140 ,  150  generates an electric charge when exposed to heat in the form of infrared radiation. The amount of charge generated is in relation to the temperature of the breast milk or formula held in container  18 . The detected charge is converted into a direct, actual temperature reading of the breast milk or formula held in container  18 . Further, it will be appreciated by those skilled in the art that in the embodiment of  FIG. 15  having an infrared sensor that extends upwardly from the bottom of well  14   a - 14   d  that the container  18  (with or without bag  16 ) could be supported directly on sensor  150  thereby eliminating the need for use of collar  72 . In the alternative a similar standoff structure could be provided to support container  18  by inserting a standoff or magnetic standoff which may be of various convenient heights into well  14   a - 14   d  to maintain container  18  above the fluid  58  level and thereby avoid the use of collar  72 .  
         [0058]     Yet another embodiment that can be employed based on the structure shown in  FIG. 15  is the use of a thermocouple to directly measure the temperature of the fluid in container  18 . In this embodiment a thermocouple in a suitable prong-like or spike structure extends upwardly from the bottom of well  14   a - 14   d  in a manner similar to that shown in  FIG. 15 . The container  18  is provided with an invagination in the bottom of container  18  that is sealed by a grommet or septum against the intrusion of heat transfer fluid  58 . Container  18  is then seated on the prong-like or spike structure containing a J thermocouple by inserting the prong-like or spike structure through the grommet or septum to place the thermocouple directly against the invagination of container  18  that is extending upwardly from the bottom of container  18  and into the center of container  18  so that the invagination is surrounded by the breast milk or formula being warmed.  
       Portable Neonate Formula Warming  
       [0059]     Referring now to  FIGS. 16, 17 , and  18  a portable warmer pouch or portable warmer device  160  is shown for use during transportation of a container  18  or dosing syringe  164  or for maintaining the temperature of a dosing syringe  164  while it is placed in a metered delivery system  170  for delivering breast milk or formula at a determined feeding rate ( FIG. 18 ). The portable warmer device is essentially a pouch or a bag having a combination a materials therein which upon selectable activation produce an exothermic reaction usually by crystallization of a supersaturated solution contained within the bag. Typically, the activation is accomplished by including a nucleating agent or seed crystal within a holder  163  that is floating within the supersaturated solution of the bag or pouch or device  160 . When it is desired to active the warming function of the bag or pouch or device  160  the holder  163  is broken or fractured and the nucleating agent or seed crystal within a holder  163  is released into the supersaturated solution and crystal formation begins within the supersaturated solution. The formation of the crystals results in heat being produced (an exothermic reaction) and this heat may then be applied to the object to be warmed.  
         [0060]     One typical combination of materials which will produce an exothermic reaction within the temperature range desired for maintaining the proper temperature for breast milk for formula is a supersaturated solution of sodium acetate (NaC 2 H 4 O 2 ). A seed crystal is then introduced into this supersaturated sodium acetate solution upon demand. This on demand insertion of the seed crystal is produced by snapping the disk  163  which is situated within package or pouch  160  and in contact with the sodium acetate solution. The introduction of the seed crystal initiates a chain reaction causing the supersaturated solution to crystallize. The crystallization process of the supersaturated solution is an exothermic reaction and produces heat within a temperature range sufficient to warm and maintain warmth of the breast milk or neonate formula which is contained within a container,  18 , or a syringe type container,  160 . When the seed crystal is introduced into the supersaturated sodium acetate solution crystals of sodium acetate begin to form and produce a release of energy or exothermic reaction and the solution temperature elevates and begins approaching the “freezing point” of sodium acetate (192° F.).  
         [0061]     Other alternative agents are available that may be used to produce the desired exothermic reaction of the crystallization of the supersaturated solution. For example, Disodium Phosphate (12 Hydrate) (Na 2 HPO 4 12H 2 O) having a melting point temperature of 36° C. (96.8° F.) (also known as Sodium Phosphate Dibasic Dodecahydrate and/or Disodium hydrogenphosphate Dodecahydrate) may be used with a nucleating agent comprised of borax or carbon or Titanium Dioxide (TiO 2 ) or copper or aluminum provided as part of nucleating device  163  ( FIG. 16 ) to initiate the crystallization reaction of the supersaturated solution of Disodium Phosphate (12 Hydrate). Alternatively, Sodium Thiosulfate (NaS 2 O 3 .5H 2 O) having a melting point of 57° C. (134.6° F.) may be used with a nucleating agent comprised of potassium sulfate or tetrasodium pyrophosphate to initiate the crystallization reaction of the supersaturated solution of sodium thiosulfate. As mentioned previously, sodium acetate (NaCH 3 CO 2 3H 2 O) (sodium acetate trihydrate) having a melting point of 46° C. (114.8° F.) may be used to form the supersaturated solution with nucleating agents such as strontium sulfate or carbon or sodium sulfate.  
         [0062]     In operation, and still referring to  FIGS. 16, 17  and  18 , the portable warming pouch  160  ( FIG. 16 ) may be applied to container  18  or syringe  164  by first activating the nucleating agent that&#39;s in nucleating agent  163  to begin the crystallization reaction and then wrapping the flexible bag or pouch  160  around the exterior surface of container  18  or syringe  164 .  
         [0063]     It will be appreciated that the temperature achieved by portable warming pouch  160  will be determined by the type of solution with which bag  160  is filled. Different solutions will produce different temperatures and therefore the user will wish to select the temperature most appropriate to the particular situation and the length of time over which warming must continue. It will also be appreciated that warming pouch  160  may be used in conjunction with an RFID device having a temperature sensing unit therein to permit the monitoring of the temperature to be conducted while the portable warming pouch or bag  160  is being applied to container  18  or syringe  164 . As shown in  FIG. 17 , an activated warming device or pouch  160  has been applied to  164  and is held in place by the use of Velcro or adhesive strap  162 . With warming bag or pouch  160  in place, the syringe can be carried to a feeding location without a reduction in temperature and can be used to feed a neonate over a period of time by extruding the breast milk or formula contained in syringe  164  out of nozzle  166  by application of plunger  168 .  
         [0064]     Referring now to  FIG. 18 , the situation frequently arises in the feeding of neonates during which syringe feeding must take place and the formula must be dispensed over a lengthy period of time. In these types of situations, a metered feeding device  170  is used to slowly extrude breast milk or formula from a syringe  164 . As shown in  FIG. 18 , a typical syringe  164  has been inserted into a metered feeding device  170  having a retractable arm  172  in contact with plunger  168  of syringe  164 . During a selected time period, the retractable arm  172  compresses against plunger  168  driving it into syringe  164  to extrude a metered quantity of breast milk or formula from syringe  164  through nozzle  166  and out of feeding tube  174 . It will be appreciated that such metered feedings will take place over a substantial segment of time during which the contents of syringe  164  can cool. This cooling of the contents of syringe  164  is alleviated by the application of portable warming pouch  160  to syringe  164  as shown in  FIG. 18 . As previously described, for  FIG. 17 , the pouch  160  is wrapped about syringe  164  after activation of the solution by the use of nucleating agent  163  to initiate the exothermic crystallization reaction within pouch  160 .  
         [0065]     In the foregoing description, certain terms have been used for brevity, clearness and understanding; but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such terms are used for descriptive purposes and are intended to be broadly construed. Moreover, the description and illustration of the inventions is by way of example, and the scope of the inventions is not limited to the exact details shown or described.  
         [0066]     Certain changes may be made in embodying the above invention, and in the construction thereof, without departing from the spirit and scope of the invention. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not meant in a limiting sense.  
         [0067]     Having now described the features, discoveries and principles of the invention, the manner in which the inventive neonate nutrition warming device and bag and collar for warming formula and nutritional media for babies are constructed and used, the characteristics of the construction, and advantageous, new and useful results obtained; the new and useful structures, devices, elements, arrangements, parts and combinations, are set forth in the appended claims.  
         [0068]     It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.