Abstract:
A system and method are provided for warming a nutritional substance (i.e. mother&#39;s milk or formulated liquids) for ingestion by a neonate. Structurally, the system includes a warmer for holding a container of the nutritional substance as it is simultaneously vibrated and warmed in preparation for the neonate, and it includes a controller which determines how the system will be operated. For an operation of the present invention, a user provides input to the system controller to establish a mode of operation (e.g. warming; warming-frozen; or thawing). The user will also input a predetermined protocol to the controller. During the operation, a heat sensor monitors temperatures of the nutritional substance which are provided as feedback input to the controller for operating the warmer in accordance with the protocol.

Description:
FIELD OF THE INVENTION 
     The present invention pertains generally to systems and methods for preparing nutritional liquids for ingestion by neonates. More particularly, the present invention pertains to systems and methods for controlling the temperature and consistency requirements that need to be achieved during a preparation of nutritional liquids for ingestion by neonates. The present invention is particularly, but not exclusively, useful as a system and method which provides for a customized preparation of nutritional liquids (substances) for ingestion by neonates, wherein the preparation is controlled under sanitary conditions to achieve specific results in accordance with a predetermined protocol. 
     BACKGROUND OF THE INVENTION 
     Preferably, neonates are suckled when fed mother&#39;s milk. For any of several different reasons, however, suckling may not be possible or convenient. In such cases, either preserved mother&#39;s milk or any of various formulated liquids may need to be substituted. Nevertheless, if the neonate cannot be suckled, the nutritional liquid that is fed to the neonate still needs to have a proper consistency, and it must also be within an appropriate temperature range. 
     Preserving mother&#39;s milk or formulated liquids for subsequent use typically requires refrigeration. This results in either cooling or freezing of the nutritional substance which, in turn, requires a subsequent thawing and/or heating of the preserved mother&#39;s milk or formulated liquid. In the event, such heating must be complete, and it must result in a homogeneous nutritional liquid. Otherwise, an improperly, non-uniformly heated nutritional liquid results, and its use may be problematical for a neonate. 
     In light of the above, it is an object of the present invention to provide a system and method for warming a nutritional substance for ingestion by a neonate which predictably prepares the nutritional substance for this purpose. Another object of the present invention is to provide a system and method for warming a nutritional substance for a neonate which can be customized to achieve the desired result, regardless of the pre-condition of the nutritional substance. Yet another object of the present invention is to provide a system and method for warming a nutritional substance for a neonate which is easy to set up, is simple to operate, and is comparatively cost effective. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention, a system for warming a nutritional substance for a neonate includes a container, such as a syringe, which is filled to hold a predetermined volume of the nutritional substance (e.g. mother&#39;s milk). The filled container is then inserted into a liquid-lined pouch. At this point, the pouch is sealed to enclose and hold the container within the pouch, and to thereby establish intimate contact between the container (nutritional substance) and the liquid-liner of the pouch. Alternatively, the liquid-lined pouch can be prefilled. Preferably, the liquid used for the liquid-lined pouch is either sanitized water or a sanitized gel type substance. 
     As a component of the system for the present invention, a nutritional warmer is provided for warming the nutritional substance in the container. Structurally, the warmer includes a base member that is formed with at least one well. Each well in the base member has a wall, and each well is dimensioned to receive a respective container in a pouch. Importantly, in this combination, contiguous contact is established between the wall of the well and the pouch, and between the pouch and the container (nutritional substance). 
     Additional components of the nutritional warmer include a heater and a vibrator. In particular, a heater is mounted on the base member, and it is selectively operated for transferring heat to the nutritional substance in the container. This, of course, is done while the container and the pouch are positioned in the well. Also, a vibrator is mounted on the base member for vibrating the well as heat is being transferred from the heater, and through the pouch, to the nutritional substance in the container. In detail, the vibrator will typically include a shaft which is connected with the well, and which is aligned with a central axis that is defined by the well. Also, the vibrator includes an off-axis weight that is connected to the well. Consequently, when the shaft is rotated by a motor, the off-axis weight will cause the well to vibrate the well. In turn, this will cause the nutritional substance (liquid) in the pouch to also be vibrated (agitated), and thereby facilitate the heating and preparation of the nutritional substance for subsequent ingestion by a neonate. 
     For operating the present invention, the system includes a controller which is mounted on the base member. Further, the controller is operationally connected with the heater and with the vibrator. Within this structural combination, the controller is selectively programmed by a user to activate both the heater and the vibrator for simultaneously heating and vibrating the nutritional substance in the container. Importantly, this operation is accomplished in accordance with a predetermined protocol which prepares the nutritional substance for subsequent ingestion by the neonate by accounting for the pre-operational condition of the nutritional substance. 
     In accordance with the present invention, an operation starts when a user provides input to the controller. In particular, the input is in two parts. One part (i.e. mode data) pertains to the initial physical condition of the nutritional substance. The other part (i.e. protocol data) pertains to the amount of the nutritional substance that is to be warmed. In use, the mode data will establish whether the nutritional substance is initially at room temperature (this requires a warming mode), whether the nutritional substance has been refrigerated (this requires a warming-frozen mode), or whether it has been previously frozen and now needs to be thawed for further short term storage (this requires the thaw mode). In any event, the protocol data is dependent on the mode data. 
     In a preferred mode of operation, the protocol data is used to establish closed loop control, using temperature feedback, for the system. More specifically, for the preferred embodiment, a maximum temperature (T max ) is established by the protocol data for the nutritional substance. As a practical matter, T max  will be in a range between 96° F. and 99° F. The controller then monitors the actual temperature (T) of the nutritional substance, as it is being warmed, to determine when T is equal to T max . When T=T max , the controller will activate an overtime modality for operation of the system, and will provide a display which will notice the user that the nutritional substance is “Ready To Feed.” For the convenience of the user, if the nutritional substance is not fed immediately to a neonate, an overtime modality is initiated by the controller which includes a pulse cycle. As intended for the present invention, the pulse cycle provides intermittent intervals for warming the nutritional substance that will keep it “Ready To Feed” for a predetermined period of time (e.g. 30 minutes). 
     In an alternate embodiment, the protocol data can be used to establish an open loop control for the system. In this case, the protocol data is selected and used according to the volume of nutritional substance that is to be prepared. Also, the protocol data establishes the appropriate rate for heating the nutritional substance for compliance with requirements of the selected mode data. More specifically, the protocol data will establish the time duration for an operation of the controller that will achieve the intended final physical characteristic of the nutritional substance. In general, the protocol data will determine an operational time duration chosen from the group consisting of 5-12 minutes for the warming mode, 10-18 minutes for the warming-frozen mode, and 15-25 minutes for the thaw mode. Additionally, the predetermined protocol will include an overtime modality disclosed above to indicate an imminent cessation of system operation. And, it will also include a standby modality to indicate an availability of the system for resumption of operation. 
     As an added feature for the present invention, the system may include a unit for sanitizing the water that is to be used for filling the liner of the pouch. If used, this unit will include a receptacle for holding water that can either be a stand-alone unit or be selectively engaged with the system&#39;s base member. Further, a source of ultra-violet (UV) light is connected with the receptacle and is provided for selectively radiating UV light through water in the receptacle. Specifically, as indicated above, this is done to sanitize the water in the receptacle for use in filling the liquid-lining of the pouch. Also, a liquid pump can be mounted on the receptacle for transferring sanitized water from the receptacle to the pouch. And, optionally, a heater can be mounted on the receptacle to pre-heat the water in the receptacle. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
         FIG. 1  is a perspective view of a warming system in accordance with the present invention; 
         FIG. 2  is an exploded perspective view of operational components of the warming system; 
         FIG. 3  is a cross-section view of selected operational components of the system for the present invention as seen, in combination, along the line  3 - 3  in  FIG. 2 ; and 
         FIG. 4  is a logic flow chart for an operation of the present invention. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring initially to  FIG. 1 , a system for warming a nutritional substance for a neonate in accordance with the present invention is shown and is generally designated  10 . As shown, the system  10  includes a base member  12  that is formed with at least one well  14 . Further, in  FIG. 1 , a pouch  16  is shown inserted into a well  14 ′. It is also shown in  FIG. 1  that the base member  12  includes a display panel  18  which presents control input pads  20 , and provides operational notices  22  that pertain to an operation of the system  10 . Additionally an adapter  24  is shown associated with the system  10 . Specifically, the adapter  24  includes a platform  26  which includes an Ultraviolet (UV) light source (not shown) for sanitizing water that is being held in the receptacle  28 . As intended for the present invention, the UV adapter  24  will preferably be of a type that is disclosed and claimed in pending U.S. patent application Ser. No. 13/967,127 by Janice M. Shields, inventor, for an invention entitled “UV Adapter for Preparation of Neonate Nutritional Fluid.” 
     Referring now to  FIG. 2 , several essential operational components for the system  10  are shown in their functional combination with each other. In particular, these components of the system  10  include a container  30  for holding a nutritional substance  32  that is to be ingested by a neonate (not shown). For the present invention, the container  30  may be a syringe, as shown, or it may be any other type of container that is well known in the pertinent art, and is useful for the purpose of holding a nutritional substance. Further, as envisioned for the present invention, the nutritional substance  32  is preferably mother&#39;s milk. The nutritional substance  32  may, however, be a prepared formula or it may be any other liquid substance that has been prescribed by appropriate medical personnel. 
     Still referring to  FIG. 2 , the pouch  16  is shown positioned to receive and enclose the container  30  with its contents, the nutritional substance  32 . As best seen in  FIG. 3 , the pouch  16  includes an inner bag  34  and an outer bag  36 . In their combination with each other, the inner bag  34  is positioned inside the outer bag  36  and their respective openings are attached to each other. Thus, a compartment is created between the inner bag  34  and the outer bag  36  for holding a sanitized water/gel  38 . Further, a fastener  40  can be provided, as shown, which can be used to enclose the container  30  within the inner bag  34 . For alternate embodiments of the present invention, the pouch  16  can either be prefilled with sanitized water/gel  38 , or it can be filled on-site by employing the UV adapter  24 . 
     As shown in  FIG. 2 , the well  14  is essentially a hollow, cylindrical shaped structure which defines a central axis  42 . The well  14  has a wall  44  with a base  45  and, as implied above, the well  14  is dimensioned to receive the pouch  16  with the container  30  enclosed in the pouch  16 . For purposes of the present invention, the wall  44  of the well  14  may be made of a metal, or it may be made of a ceramic or include a ceramic liner. In any case, it is important that the wall  44  of well  14 , and its base  45 , be made of a heat conductive material. 
       FIG. 2  also shows that the system  10  includes a controller  46  that is electronically connected with a heat sensor  48 , a heater  50 , and a vibrator  52 . With this combination, it is to be appreciated that the controller  46  is also electronically connected to the control input pads  20  shown in  FIG. 1 . Further, by cross referencing  FIG. 2  with  FIG. 3 , it will be seen that the heat sensor  48  is connected to a thermistor  54  that is affixed to base  45  of the wall  44  of well  14 . It will also be seen that the heater  50  is connected with a heating coil  56  that is positioned on the wall  44  to surround the well  14 . Additionally, the system  10  includes a shaft  58  which interconnects the vibrator  52  with the well  14 . With this interconnection, it is to be further appreciated that the vibrator  52  includes a motor (not shown) which will rotate the shaft  58  at an angular velocity w. As a consequence of this rotation, an off-axis weight  60  that is attached to the shaft  58  will vibrate the well  14 . Specifically, with an end of the shaft  58  positioned in a recess  62  that is located on the base  45  of wall  44 , the shaft  58  can be rotated independently of the well  14 . The consequence here is that the off-axis weight  60  will cause flexions of the shaft  58  as the shaft  58  is rotated. In turn, these flexions will vibrate the well  14 . 
     For an operational set up of the system  10 ,  FIG. 4  indicates that the first task here involves programming the controller  46  (see action block  64 ). Specifically, this requires use of the control input pads  20  to input mode data (see action block  66 ) and protocol data (see action block  68 ). Whether this input has been completed, and has been properly accomplished, is checked (see inquiry blocks  70  and  72 ) before the system  10  is operated (see action block  74 ). 
     An operation of the system  10  effectively depends on the mode data and the protocol data that is input to the controller  46  (see action blocks  66  and  68 ). In general, the mode data will be indicative of an initial physical characteristic of the nutritional substance  32 . For instance, the mode data will establish whether the nutritional substance  32 : a) is initially at room temperature (this requires a warming mode); b) has been refrigerated (this requires a warming-frozen mode); or c) has been previously frozen and now needs to be thawed for further short term storage (this requires a thawing mode). On the other hand, the protocol data will be based on the size and volume of the nutritional substance  32  that is to be warmed. The purpose here is to operate the system  10  according to a predetermined protocol that will achieve an intended final, physical characteristic for the nutritional substance  32 . To do this, the protocol data will establish whether the system  10  will operate with an open loop control, or with a closed loop, feedback control. 
     In a preferred mode of operation for the system  10 , the protocol data that is used will establish a closed loop control, using temperature feedback. In this case a maximum temperature (T max ) for the nutritional substance  32  is established by the protocol data that is input to the controller  46  (see action block  68 ). Typically, T max  will be in a range between 96° F. and 99° F. When the nutritional substance  32  is to be thawed, however, T max  may more appropriately be established at, or below, room temperature for storage and/or refrigeration. 
     During a closed loop control of the system  10 , the controller  46  uses the heat sensor  48  and its thermistor  54  to continuously monitor the actual temperature (T) of the nutritional substance. When T is equal to T max  (see inquiry block  76 ) the controller  46  will provide a notice  22  on the display panel  18  for the user. Specifically, this notice  22  will indicate that the nutritional substance  32  is “Ready To Feed” (see action block  78 ). Alternatively, a notice  22  can be given that the nutritional substance  32  has been thawed. In any event, the system  10  will deactivate the heater  50  and determine whether the pouch  16  has been removed from the well  14  (see inquiry block  80 ). As envisioned for the present invention, the determination concerning removal of the pouch  16  can be made in any manner well known in the pertinent art, such as by using a light switch (not shown). 
     For the convenience of the user, if the pouch  16  has not been removed from the well  14 , an overtime modality is initiated by the controller  46 . If the overtime modality is used, an inquiry is made into whether the overtime has expired (see inquiry block  82 ). If overtime has not expired, a pulse cycle is activated (see action block  84 ). As intended for the present invention, the pulse cycle provides for warming the nutritional substance  32  during intermittent time intervals (e.g. warming for one out of every five minutes) established by the protocol data during set up. The intended result here is to keep the nutritional substance  32  “Ready To Feed” for a predetermined period of time (e.g. 30 minutes). 
     As indicated above, for an alternative to closed loop control, the protocol data can be used to establish an open loop control for the system  10 . In this case, the protocol data is selected and is used according to the volume of nutritional substance  32  that is to be prepared. Also, the protocol data establishes an appropriate rate for a heating of the nutritional substance  32  that will comply with requirements of the selected mode data. More specifically, the protocol data will establish the time duration for an operation of the controller  46  that will achieve the intended final, physical characteristic of the nutritional substance. In general, the protocol data will determine an operational time duration that may be 5-12 minutes for the warming mode, 10-18 minutes for the warming-frozen mode, or 15-25 minutes for the thaw mode. Additionally, like the closed loop control, the predetermined protocol for open loop control will include the overtime modality that is disclosed above to maintain the nutritional substance at the appropriate temperature and to indicate an imminent cessation of system operation. Regardless of other control considerations, a standby modality to indicate an availability of the system for resumption of operation can be provided. 
     While the particular Electronically Controlled Nutritional Fluid Warmer as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.