Patent Publication Number: US-2007118078-A1

Title: Method and apparatus for controlled feeding of an infant

Description:
BACKGROUND OF THE INVENTION  
      1. The Field of the Invention  
      The present invention relates to a method and apparatus for controlled feeding of a neonatal or pediatric infant. More specifically, the present invention relates to the use of an enteral feeding pump for gastroinstestinal or nasoenteric enteral feeding of an infant and relates to a variety of containers which can be used to improve neonatal or pediatric feeding. The present invention also relates to a method for improving the delivery of enteral feeding solutions for patient&#39;s of all ages.  
      2. State of the Art  
      Many infants which are born prematurely or which are smaller or underdeveloped do not have sufficient mouth strength to feed normally. That is to say that many premature infants do not have sufficient strength to breast feed or to draw milk from a bottle. For some infants, it is sufficient to place an nasoenteric feeding tube and allow gravity to feed the breast milk or other feeding solution to the child.  
      Other infants, however, are not able to handle a large dose of feeding solution in a relatively short amount of time. These infants are typically fed using a feeding pump which pumps the milk, etc. through a nasal feeding tube which has been placed through the nose and into the stomach or through an enteral feeding tube placed in a stoma in the stomach wall. Due to their size, many neonatal infants require very slow administration of feeding solution, on the order of 1 mL per hour. In some cases, the desired administration rate may be as low as 0.1 mL per hour. There is thus a need for a neonatal feeding pump and system which is capable of delivering a feeding solution at a slow rate, and which is very precise.  
      Currently, syringe pumps are most often used to feed such neonatal infants. Available peristaltic pumps are typically designed for the enteral feeding of adults and children and generally pump the solution too fast, and are not accurate enough for neonatal use. Thus, syringe pumps are used. Syringe pumps are also commonly used for introducing medication into an I.V. line for administration to a patient. Thus, the syringe pumps are very accurate and designed for low flow rates. When syringe pumps are used for neonatal feeding, it is necessary to transfer breast milk from the breast pump reservoir to a syringe prior to delivery to an infant, increasing the risk of contaminating the milk and the complexity of the feeding procedure. Additionally, syringe pumps are often more expensive than other types of pumps, such as peristaltic pumps, making them impractical for home use and increasing the cost of owning these pumps for a hospital.  
      The expense of the syringe pumps makes them generally unavailable for home use and requires that the neonatal infant remain in the hospital until the infant is capable of feeding from a bottle or breast feeding, or is capable of receiving the higher volume of feeding solution delivered from a typical enteral feeding pump. This can increase the time that the infant is in the hospital, also increasing the cost of the hospital stay.  
      Yet another concern with the delivery of feeding fluid to an infant is separation within the fluid. In most situations, the food of choice for a neonatal infant is breast milk. However, because relatively small quantities of the breast milk are being delivered, a feeding container with a substantial amount of breast milk will have time for the breast milk to separate. Needed fats will separate out from the milk and rise, leaving a watery mixture of proteins and sugars. This can provide inconsistent nutrients to the infant. Additionally, because such small doses of the milk are administered, a large container of milk may have time to spoil or culture bacterial growth. Furthermore, some conventional feeding sets can include 15 ml of solution withing the feeding set alone, thereby increasing the risk of spoilage or waste of precious feeding solution—such as breast milk. Thus, it is desirable to provide containers which contain relatively small amounts of breast milk or other feeding solutions. Likewise, it is desirable to minimize the risk of, separation which could result in some doses of the milk being watery proteins and sugars, while other doses are principally milk fats.  
      In addition to the above, there is a need to keep safety at the forefront when feeding the neonatal infant. Safety concerns with syringe feeding pumps include the possibility that feeding solution may be administered through an intravenous line, leading to the possible harm or even death of the patient. Enteral feeding set are typically formed with non-IV compatible adaptors for connection to feeding tubes. If tubing connections are not propery controlled, the tubing from one system (such as feeding) may inadvertently become confused or tangled with tubing from another system, such as that designed for IV medictions.  
      There is thus a need for a neonatal feeding system which is easier and more convenient to use, and which provides increase control, facilitates lower storage volumes and increased safety. There is also a need for a neonatal feeding system which is less expensive than the currently available syringe pumps used for feeding. A neonatal feeding system which is easier to use, safer and less expensive may allow parents to take premature infants home from the hospital earlier.  
     SUMMARY OF THE INVENTION  
      It is an object of the present invention to provide an improved feeding apparatus and method of use for controlled feeding of infants. According to one aspect of the present invention, a feeding system is provided which is easier to use, safer and provides more reliable nutrition to the infant. This can be accomplished in several ways including reduced storage volumes, more consistent solution delivery, and reduced risk of error in connection with the patient&#39;s feeding tube.  
      In accordance with one aspect of the invention, the feeding system may be designed such that the feeding solution reservoir is usable with breast pumps, allowing the milk to be delivered to an infant without unnecessary transfer of the milk between containers. If desired, an insert or adapter may be provided which allows conventional bottles or breast pump reservoirs to be connected to the tubing of an enteral feeding set and thereby to the pump for delivery to an infant. As such the risk of contamination is decreased and the cost of the system is reduced.  
      According to another aspect of the present invention, a feeding solution reservoir is provided which prevents the formation of a partial vacuum inside of the reservoir as solution is drawn from the reservoir. A feeding solution reservoir may be collapsible as the feeding solution is drawn from the reservoir, preventing a partial vacuum inside of the reservoir without requiring a vent. Alternatively, a vent may be provided whereby air is allowed to enter the reservoir as the solution is drawn from the reservoir. Such a configuration reduces the amount of work necessary for a pump, such as a peristaltic enteral feeding pump, to draw the breast milk or other feeding solution from the container for delivery to the child. Those skilled in the art will appreciate that if the container/reservoir is a syringe, most enteral feeding pumps will not generate sufficient suction on the upstream or inlet portion of the infusion set to reliably draw the breast milk or other feeding solution from the syringe.  
      According to another aspect of the present invention, an infusion set may be provided which is designed for the feeding of neonatal infants. The infusion set may have a distal end thereof which is tapered or which is formed in a size and shape suitable for nasal feeding of a neonatal infant. Additionally, an infusion set may be provided which has an adapter configured for attachment directly to a feeding reservoir, such as a bottle or breast pump reservoir.  
      In accordance with another aspect of the present invention, the storage container or reservoir may be very small, such as a syringe, and be provided with affirmative force, such as a spring or elastomeric biasing element, to assist the pump in drawing the feeding solution from the container.  
      In accordance with yet another aspect of the present invention, the storage container is configured to minimize the overall separation of the breast milk or other feeding solution within the container. This can be done by utilizing a syringe in conjunction with an enternal feeding pump, or by utilizing custom containers which minimize overall separation.  
      In addition to concerns regarding the nutritional nature of each dose of feeding solution received by the child, another concern in enteral feeding can be separation of the feeding solution and medicine or other solutions mixed therewith. For some infants and even some children and adults, it is necessary to mix medicines into the feeding solution for delivery to the patient&#39;s digestive system. Because some medicines, etc., have different densities than the feeding solution, or my be less soluble in the feeding solution, separation can be a problem. In some extreme cases, parents or patients are required to wake every hour and shake the solution container to ensure that the medicine is not separating out of the solution. Failure to do so can result in inadequate doses of the medicine, followed by excessive doses. Thus, minimizing separation not only improves nutritional solution delivery, it can also be critical to proper medicinal therapy.  
      It will be appreciated that the various aspects of the invention may not all be found present in embodiments which are made in accordance with the individual aspects of the invention and there is no requirement that any embodiment containing one or more aspects of the present invention include other aspects of the present invention. Rather, the claims are drawn to the various aspects of the invention and should not be viewed as requiring elements or aspects not set forth specifically therein. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      Various embodiments of the present invention are shown and described in reference to the numbered drawings wherein:  
       FIG. 1  shows a perspective view of a neonatal feeding pump as is known in the prior art;  
       FIG. 2  shows a perspective view of a neonatal feeding system according to the present invention;  
       FIG. 3  shows a side view of a feeding solution reservoir according to the present invention;  
       FIG. 4  shows a side view of an insert for connecting a bottle to an infusion set according to the present invention;  
       FIG. 5  shows a side view of another feeding solution reservoir according to the present invention;  
       FIG. 6  shows a side view of an adapter according to the present invention;  
       FIG. 7  shows a side view of another adapter according to the present invention;  
       FIG. 8  shows a side view of another feeding solution reservoir according to the present invention;  
       FIG. 9A  shows a side view of a syringe being filled in accordance with the present invention;  
       FIG. 9B  shows the syringe of  FIG. 9A  being attached to the infusion set configured for use with a peristaltic enteral feeding pump;  
       FIG. 9C  shows the infusion set being loaded into an enteral feeding pump;  
       FIG. 9D  shows the infusion set and pump being attached to a custom bracket or mount to facilitate delivery of the breast milk or other feeding solution from the syringe to an infant;  
       FIG. 10A  shows a front view of an enteral feeding pump and feeding solution reservoir in accordance with another aspect of the present invention;  
       FIG. 10B  shows a top view of the pump and feeding solution reservoir of  FIG. 10A ;  
       FIG. 10C  shows an end view of the pump and feeding solution reservoir of  FIGs. 10A and 10B .  
       FIG. 11A  shows a front view of an enteral feeding pump and feeding solution reservoir in accordance with another aspect of the present invention;  
       FIG. 11B  shows a top view of the pump and feeding solution reservoir of  FIG. 11A ;  
       FIG. 11C  shows an end view of the pump and feeding solution reservoir of  FIGs. 11A and 11B ;  
       FIG. 12A  shows a front view of an enteral feeding pump and feeding solution reservoir in accordance with another aspect of the present invention;  
       FIG. 12B  shows a top view of the pump and feeding solution reservoir of  FIG. 12A ;  
       FIG. 12C  shows an end view of the pump and feeding solution reservoir of  FIGS. 12A and 12B ;  
       FIG. 13  shows a side view of an alternate configuration of a solution container in accordance with the principles of the present invention;  
       FIG. 14  shows a front view of an enteral feeding pump similar to that of  FIG. 12A  with a shaking mechanism for minimizing fluid separation.  
       FIG. 15A  shows a cross-section view of an alternate configuration of a solution container designed to minimize separation within the enteral feeding solution prior to delivery to the patient;  
       FIG. 15B  shows a side view of the solution container of  FIG. 14A ;  
       FIG. 15C  shows an end view of the solution container disposed on a rocker motor;  
       FIG. 16A  shows a side view of an alternate configuration of a solution container designed minimize separation within the feeding solution;  
       FIG. 16B  shows another view of the solution container of  FIG. 16A , wherein the pump is mixing the contents of the container.  
       FIG. 17A  shows an alternate embodiment of a solution container for minimizing separation of solution;  
       FIGS. 17B, 17C  and  17 D show additional details of and alternate positions of the solution container in  FIG. 17 ; and  
       FIGS. 18A and 18B  show static mixers for minimizing fluid separation within the enteral feeding solution. 
    
    
      It will be appreciated that the drawings are illustrative and not limiting of the scope of the invention which is defined by the appended claims. The various embodiments shown accomplish various aspects and objects of the invention, and no one embodiment need accomplish all aspects of the invention.  
     DETAILED DESCRIPTION  
      The drawings will now be discussed in reference to the numerals provided thereon so as to enable one skilled in the art to practice the present invention. The drawings and descriptions are exemplary of various aspects of the invention and are not intended to narrow the scope of the appended claims. Nor is it suggested that any embodiment of one aspect of the invention must include other aspects discussed herein.  
      Turning to  FIG. 1 , a perspective view of a feeding system known in the prior art is shown. The feeding system uses a syringe pump  2  to provide feeding solution to a neonatal infant. As previously mentioned, syringe pumps  2  are sufficiently accurate and provide a low enough flow rate to be useful for neonatal feeding. Syringe pumps  2  often are, however, expensive. This limits the availability of the pumps  2 , inhibiting smaller institutions and individual persons from owning such pumps. Additionally, once the child grows, the child will typically be transitioned to an enteral feeding pump as he or she grows if enteral feeding is still necessary.  
      In the prior art configuration, a syringe  4  is filled with feeding solution, which is commonly breast milk. The use of a syringe requires the caregiver to transfer the feeding solution from a container holding the solution into the syringe  4 .  
      It will be appreciated by those of skill in the art that the availability of breast milk creates potential complications. Many neonatal infants must stay in an intensive care unit for a prolonged period of time. Thus, it is common for the mother of the infant to be released long before the infant. In such situations, the infant may require milk at numerous times that the mother is not present. Thus, it is common for the mother to use a breast pump and to bring in a certain quantity of breast milk which may last for 12 hours or more. To minimize the risk of bacterial growth, any breast milk not being immediately used is kept in a refrigerator. Additionally, the larger quantity of breast milk allows for small doses to be given to the child at any time needed.  
      The filled syringe  4  is connected to tubing  6  which delivers the solution to the infant (not shown). The syringe  4  is then mounted in the pump  2 , which holds the syringe  4  and gradually pushes on the syringe plunger  8  to thereby expel the feeding solution from the syringe  4  and deliver the solution to an infant. A control panel  10  is typically provided whereby the caregiver may adjust the flow rate of the pump.  
      The expense of syringe pumps  2  typically prevent an individual from owning such a pump, and thus requires that neonatal infants are kept in a hospital until able to feed without the assistance of a pump, or until able to tolerate the higher flow rate of a typical feeding pump. Many neonatal infants are sufficiently healthy to leave the hospital, and are only kept in the hospital because of the need for a neonatal feeding pump. Additionally, those infants that will require further enteral feeding after they have grown sufficiently will be transitioned to a more conventional enteral feeding pump—typically a peristaltic pump.  
      Turning now to  FIG. 2 , a perspective view of a feeding system according to the present invention is shown. The feeding system includes a pump  12 , reservoir  14 , and an infusion or feeding set  18 , including a proximal portion  18   a  of the infusion set  18 , and a distal portion  18   b  of feeding set  18 . The reservoir  14  holds the solution to be delivered to the infant, commonly breast milk. The reservoir  14  may be a bottle or pouch, and may advantageously be the same type of container as may be connected to a breast pump. Accordingly, an adapter  26  may be provided to facilitate connection of the reservoir  14  to a proximal (or upstream) portion  18   a  of the feeding set  18 . The feeding set  18  carries the feeding solution to the pump  12  which controls further flow of the feeding solution through the downstream or distal portion  18   b  of the feeding set  18 .  
      According to a presently preferred embodiment of the present invention, the pump  12  is a peristaltic pump, which engages the feeding tube  18  non-invasively so that the distal portion  18   b  of the feeding set  18  carries the feeding solution from the pump  12  to an infant (not shown). The INFINITY® peristaltic pump manufactured by ZEVEX, Inc. of Salt Lake City, Utah, has been manufactured so as to be suitable for neonatal feeding, as well as for general enteral feeding. The INFINITY® pump can deliver a flow rate which is slow enough and sufficiently accurate for neonatal infants, as well as higher rates appropriate for older children and even adults. Various aspects of the INFINITY® pump and associated feeding sets are described in greater detail in U.S. Pat. Nos. 6,523,414, 6,595,950, 6,659,976, 6,685,670, 6,750,468, 6,852,094, and 6,907,788. Peristaltic pumps are advantageous as they are generally less expensive than syringe pumps. Peristaltic pumps are also easy to use and minimize the risk of contamination. The pump rotor of a peristaltic pump does not contact the feeding solution carried inside of the feeding set, eliminating the risk of contaminating the feeding solution by a poorly cleaned pump. Furthermore, peristaltic pumps are often more convenient in that they may be used in a variety of orientations, such as being mounted on a pole, attached to the side of a bed, or simply placed on a table adjacent the child.  
      A feeding set may be loaded into a peristaltic pump simply by wrapping the feeding set tubing around the pump rotor and securing the feeding set tubing to the pump body. Additionally, peristaltic pumps may be formed so as to work with a cartridge which carries the feeding set and is easily loaded into the pump with one hand. A cartridge typically connects the proximal portion  18   a  of the feeding set to an intermediate or central pumping portion of the feeding set (not shown) which is typically a piece of soft tubing such as silicone tubing, and would also connect the other end of the central pumping portion to the distal portion  18   b  of the feeding set  18 . Thus, an feeding set may be provided which contains the proximal and distal portions of the feeding set, the pumping portion of the feeding set, a section of tubing configured for enteral feeding of an infant, and a connector or adapter configured for attaching the feeding set to a convenient feeding solution reservoir, such as a breast pump reservoir. The feeding set may also be provided with a peristaltic pump cartridge if required.  
      The entire feeding set may thus be provided as a sterile and disposable unit whereby an individual need only load the feeding set into the pump, connect the feeding solution reservoir, properly place the feeding tubing in the infant, and start the pump. Once the feeding has been completed, any excess feeding solution may be disposed of. The use of such an feeding set minimizes the risk of contamination of the feeding solution or improper use of the pump and feeding system.  
      The proximal portion  18   a  of the feeding set  18  may have an adapter  26  integrally formed onto or attached to an end thereof. The adapter  26  may be selected to allow a bottle, breast pump reservoir, or other convenient feeding solution reservoir to be easily attached to the feeding set  18 . The distal portion  18   b  of the feeding set  18  may be selected so as to be an appropriate size for enteral feeding, may have a section of tubing  30  which is tapered or otherwise configured for enteral feeding, or may have a connector  22  (preferably non-IV compatible) which connects the distal portion  18   b  of the feeding set  18  to a section of tubing  30  configured for the enteral feeding. If the section of tubing  30  is configured for nasal feeding, it will typically be formed of an appropriate material and in an appropriate size to be sufficiently flexible for insertion into the infant&#39;s nasal passage. Additionally, coatings are available which make the tube easier to insert into the nasal passage. The selection of a particular shape, size, material, and coating for a nasal feeding tube will be known to one of skill in the art of nasal feeding or in the catheter art.  
      The reservoir  14  may take many forms, such as bottles or pouches. For some reservoir shapes, it is desirable to hang the reservoir  14  to ensure the proper flow of fluid and to prevent air from entering the tubing  18 . A bracket or tab  16  may be provided on the reservoir  14  to allow an individual to hang the reservoir. If necessary, a cage or basket  20  may be provided which holds the reservoir  14  and allows for hanging of the reservoir. A pole or stand, such as an I.V. stand, or even the rails of a crib or bassinet may be used to hang the reservoir  14  if necessary. However, as well be discussed in additional detail below, hanging any quantity of breast milk for a prolonged period of time can be problematic because it can encourage separation of the breast milk, with the proteins, water and sugars settling to the bottom, while the milk fats rise to the top.  
      Turning now to  FIG. 3 , a side view of a feeding solution reservoir according to one aspect of the present invention is shown. The reservoir  14  has a bottle  40  and cap  44  which typically have threads  48  to attach the cap to the bottle (although other connection means may be used). The bottle  40  and cap  44  may be a standard baby bottle or breast pump bottle, or may have the same size threads so as to be interchangeable with these bottles. Typically, the caps  44  of baby or breast pump bottles may have an opening  52  formed therein, allowing a feeding nipple or storage insert to be inserted into the cap. Thus, an insert  56  may be provided which fits the opening  52 , and which allows the reservoir  14  to be connected to the pump. The insert  56  may have a connector  60  to which the proximal portion  18   a  of the feeding set  18  is attached, have a hole for receiving the proximal portion  18   a , or may be formed with feeding set  18  already attached. Additionally, the insert  56  may be formed with a vent  64  or be configured to receive a vent. The vent  64  prevents a vacuum from being formed as the feeding solution is drawn from the bottle  40 . A filter  68  may be attached to the vent  64  which prevents liquid or solid matter from passing through the vent  64 , but which allows air to enter as the feeding solution is drawn from the bottle  40 . It will also be appreciated that the insert  56  may have locations wherein a person may easily pierce the insert  56  and thereby connect a vent  64  and feeding tubing  18 .  
      Turning now to  FIG. 4 , a perspective view of a reservoir insert according to the present invention is shown. The insert  56  is typically formed from a flexible material, such as rubber or silicone, and has been formed to fit with a cap and bottle such as shown in  FIG. 3 . A shoulder  58  is formed on the insert  56  so as to fit in the hole commonly found on the bottle caps. The insert  56  is configured to function with a vented spike type of feeding tubing connector  80 . The connector  80  has a spike  84  which is used to pierce the insert  56 . Accordingly, the insert  56  may have an area  88  which is easily pierced. This area  88  may be thinner, may have a hole partially formed therein, etc.  
      The spike  84  has a fluid carrying tube  92  and an air carrying tube  96 . The fluid carrying tube  92  is connected to the proximal portion  18   a  of the feeding set  18 , and the air carrying tube  96  is connected to an air vent  100 . As liquid is drawn out of the feeding reservoir and into the feeding set  18 , air is drawn into the vent  100  and through tube  96  and into the reservoir, preventing a vacuum from forming in the reservoir. The vented spike connector  80  may be part of a disposable feeding set. The insert  56  may be reusable or disposable as is desired. The insert  56  may be sufficiently inexpensive to be disposed after each use, preventing contamination of subsequent feedings from improper cleaning of the insert  56 .  
      It will also be appreciated that the vented spike connector  80  and the insert  56  may be formed as a single piece. It may be desirable to dispose of the insert  56 , connector  80 , and feeding set  18  after use to prevent the contamination which could result from improper cleaning of the feeding set  18 . If the feeding set  18  is designed to be disposable, it may be more cost effective to form the connector  80  and insert  56  as a single piece.  
      Turning now to  FIG. 5 , a perspective view of another reservoir according to the present invention is shown. The reservoir  14  has a cylindrical portion  110  which is sized to hold an appropriate amount of feeding solution. The cylindrical portion  110  may have markings or graduations  114  whereby a person may easily know how much liquid is in the reservoir  14 . The cylindrical portion  110  is connected to a base  118  which has a tip  122  configured for attachment to the proximal portion  18   a  of the feeding set  18  ( FIG. 1 ). The tip  122  may be tapered so as to be insertable into the feeding set  18 , or may have a connector or appropriate shape formed therein for connection to the feeding set  18 . Alternatively, reservoir  14  may be formed integrally with the proximal portion  18   a  of the feeding set  18  ( FIG. 2 ) such that the tip  122  is connected to the proximal portion  18   a  of the feeding set  18 .  
      The reservoir  14  may be formed so as to be generally rigid, and a cap  126  may be placed on the cylindrical portion  110  to seal the reservoir. Alternatively, the reservoir  14 , and the cylindrical portion  110  in particular, may be flexible. A clip  130  may be used to close the tip  122  or the cylindrical portion  110  after filling with feeding solution so as to slectively control the size of the reservoir  14 . The clip  130  may have a base  134  and an arm  138  which close together, and a latch  142  which engages a portion of the base  130 , such as hole  146 , to hold the clip closed. The cylindrical portion  10  of the reservoir  14  would preferably be sufficiently flexible that it is easily folded flat and placed in the clip  130 , and that the cylindrical portion  110  is flattened or collapsed as the feeding solution is drawn from the reservoir  14 , preventing a vacuum from forming inside of the reservoir. The clip  130  may be placed on the reservoir  14  so as to eliminate air from the reservoir, allowing the reservoir to operate in many positions independent of a hanging pole, etc., without introducing air into the proximal tubing  18   a.    
      Turning now to  FIG. 6 , a side view of an adapter according to the present invention is shown. The adapter  26  is configured for attaching a feeding reservoir to an feeding set  18  to thereby feed a neonatal infant. The adapter  26  is configured for use with a baby bottle or breast pump bottle and is accordingly provided with threads  154  configured for attachment to such a bottle. The adapter  26  serves as a cap for the bottle. A spike  158  is formed with a fluid outlet  162  which is connected to a tip  166  via channel  170 . Feeding solution flows into the opening  162 , through the channel  170 , through tip  166 , and into the feeding set  18  as the pump  12  ( FIG. 2 ) draws fluid from the reservoir. An air opening  174  and channel  178  allow air to flow into the reservoir to prevent the formation of a vacuum as the feeding solution is withdrawn from the reservoir.  
      Those skilled in the art will appreciate that it may be desirable to use a relatively small bottle with the adaptor  26 , i.e. a few milliliters, so that the solution in the bottle does not hang for a prolonged period of time. The longer the solution hangs, the more likely it is that there will be separation between the milk fats and the proteins and sugars. This can result in the neonatal infant getting inconsistent amounts of nutrients, where it is generally desirable for the feeding solution to be relatively consistent. Once the child is able to eat in larger volumes or at faster flow rates, a similar adaptor  26  can be used with a larger bottle, as the larger volume of breast milk will have less time in which to separate.  
      Turning now to  FIG. 7 , a side view of an adapter according to the present invention is shown. The adapter  26  is designed to replace the cap of a baby bottle or breast pump bottle, and accordingly is formed with threads  180  configured for engaging such a bottle. As noted above, the bottle can be configured to contain any desired volume of feeding solution.  
      The adapter has a first connector  184  through which a first channel  188  passes, and a second connector  192  through which a second channel  196  passes. The adapter  26  may be configured such that the feeding set  18  is connected to the first connector  184  and draws liquid through the first channel  188  with the bottle in an inverted position. Air is then allowed to enter the bottle through channel  196  to prevent the formation of a vacuum. Alternatively, the adapter  26  could be configured such that the feeding set  18  is connected to the second connector  192  such that the pump draws feeding solution from the second channel  196  with the bottle in an upright position, allowing air to enter through the first channel  188 .  
      It may be advantageous to provide an adapter  26  which allows for the bottle of feeding solution to be maintained in an upright or inverted position as is necessary for a particular application. It is further advantageous to provide a simple to use and inexpensive cap to allow a conventional baby bottle or breast pump bottle to be used as a neonatal feeding reservoir. This allows the feeding solution, typically milk, to be easily provided to the infant with a minimal risk of contamination. The adapter  26  may also be produced for a low cost, allowing the adapter  26  to be discarded after each use, reducing the risk of contamination of the feeding solution. For safety reasons, the adapter should be configured to only attach to other enteral feeding connections and not compatible with parenteral IV luer adapters.  
      Turning now to  FIG. 8 , a perspective view of another reservoir according to the present invention is shown. The reservoir  214  is formed from a syringe, having a syringe body  216  and plunger  220 . The syringe body  216  may be selected to have an elongate tip  224  to which the feeding set  18  may be attached. Alternatively, the syringe body  216  may have a specialized adapter formed thereon for receiving the feeding set  18  or an intermediate connector (not shown). By withdrawing the plunger  220  and piston  228  from the syringe body  216 , an individual may draw milk or another feeding solution into the syringe. As the pump  12  ( FIG. 1 ) draws milk out of the reservoir  214 , the syringe plunger  220  may move unassisted back into the syringe body  216 . Most syringes, however, are sufficiently resistant to movement that an enteral feeding pump cannot generate a sufficient vacuum to draw the plunger  220  toward the tip  224 . This creates an undesirable vacuum within the syringe. To remedy such a situation, one or more mechanical biasing elements or members  230  may be used to urge the plunger  220  into the body  216 .  
      The biasing member may be a spring or elastomeric material such as rubber. The reservoir  214  shown would allow a user to avoid the introduction of air bubbles into the solution and avoid the formation of a vacuum within the reservoir  214  while dispensing the feeding solution. While requiring the transferring of the feeding solution into the syringe, the use of a syringe of a reservoir is advantageous as syringes are readily available and disposable, and provides a reservoir which does not require a vent to eliminate the formation of a vacuum within the reservoir. Additionally, the configuration of the reservoir  214  allows it to be used regardless of orientation. Thus, the syringe can be laid on its side where there will be less separation of breast milk contained therein. Additionally, even if there is separation, the variance in the solution delivered will be lower, as the piston  220  would tend to force both milk fats (at the top) and proteins/sugars (at the bottom) into the tube  18  simultaneously. If the syringe is held upright as shown in  FIG. 8 , watery solution with protein and sugars would tend to be fed to the neonatal infant first, while the richer milk fats would be provided last.  
      Turning now to  FIG. 9A , there is shown a side view of a syringe  250  being used to draw breast milk from a container  254 . As was mentioned previously, many neonatal infants are only able to eat in very small quantities. Thus it is common for the mother to use a breast pump and provide an amount of breast milk which will cover multiple feedings. The unused breast milk is kept in a refrigerator to minimize bacterial growth. One advantage of using the syringe  250  is that it enables the user to easily determine the amount of breast milk which has been withdrawn. Thus, it is easy to record the volume of milk being delivered to the neonatal infant.  
      Turning now to  FIG. 9B , there is shown a side view of the syringe  250  being connected to the cassette  260  of an enteral feeding set  264 . The cassette includes an inlet (upstream) tubing  268 , an intermediate portion  272  configured for engaging the rotors of the feeding pump, and outflow (downstream) tubing  276  for delivering the feeding solution to the neonatal infant. As shown, the syringe  250  may be connected to an adapter or luer  258  which is attached to or formed as part of the inlet tubing  268 .  
      As shown in  FIG. 9B , the outflow tubing  276  is preferably a coiled microbore or minibore tubing. The coil allows the tubing  276  to stretch to the patient, but keeps it from becoming tangled in other tubing and wires which may be used to monitor the patient, provide I.V. drug administration, etc. Preferably, the tubing is constructed from a material which maintains a mechanical memory to ensure a kink free, non-restrictive flow of breast milk. The microbore or minibore also allows very finite amounts of breast milk or other feeding solutions to held or contained prior to delivery to the neonatal infant. Thus, it is preferable that the tubing  276  also has a small bore extending therethrough. The small inner diameter of the microbore tubing also aids in minimizing the separation of the fats from the watery portion of the breast milk.  
      Turning now to  FIG. 9C  there is shown a perspective view of the cassette  260  being loaded into an enteral feeding pump  280 . The intermediate portion (or pump rotor tubing segment)  272  is wrapped around the rotor  284  of the enteral feeding pump and the cassette  260  nested in place. A door  288  of the pump  280  is then shut to hold the cassette in place.  
       FIG. 9D  shows the enteral feeding pump  280 , and the syringe  250  disposed on a mount  290 . The mount  290  may be configured to receive the pump  280  and hold it to a support, such as an I.V. pole  294 , or may be configured to simply attach to the pump  280 . The mount  290  is also preferably configured to hold the syringe  250  and preferably includes a biasing member  298  which applies force to the piston  252  of the syringe. Those skilled in the art will appreciate that the biasing member  296  can use springs or elastomeric elements  298  to apply pressure to the piston sufficient that the suction provided by the enteral feeding pump will draw the breast milk or other feeding solution from the syringe  250 , through the inlet tubing  268 , and pump it through the downstream tubing  276  to the patient.  
      Turning now to  FIG. 10A , there is shown an alternate embodiment of the invention. The enteral feeding pump  280  is attached to an IV pole  294 . If desired, the pump  280  can be attached to a bed rail, or simply disposed on any suitable surface.  
      Attached to the enteral feeding pump  280  is a mount  300 . Rather than a syringe, the inlet tubing  268  of the feeding set is attached to a reservoir in the form of a radially expandable container  304 . The container  304  is preferably made from an elastameric material. Being elastomeric in construction, the container  304  will act as its own infusion device creating a positive interal pressure when filled with breast milk. This will aid in delivering the breast milk to the pump, thus minimizing fluid separation and eliminating a partial vacuum.  
      Disposed on the container  304  is an injection port  308  having a one-way valve. This allows a user to inject the milk into the container  304 . The milk is then drawn out of the container, through the inlet tubing  268  and out to the patient through the downstream tubing  276 . One advantage of the container  304  is that it can hold small quantities of milk (anywhere from 5 mL to 150 mL depending on intended use). Additionally, because contents of the container  304  extend generally horizontally, any separation between milk proteins and sugars and the milk fats is minimized. As the milk is withdrawn laterally from the container, a more even blend of fats, milk proteins, and sugars is delivered to the infant. A static mixer  270  can also be included. As will be explained in additional detail below, a static mixer  270  helps to minimize separation of the milk fats from the water and proteins.  
       FIGS. 10B and 10C  show a top view and a side view, respectively, of the pump  280 , inlet and outlet tubing  268 ,  276  and the mount  300  and container  304 . The pump  280  and mount  300  are held to an IV pole  294  by a clamp  312 . Such clamps are well known in the enteral feeding arts. The clamp  312  includes a first end  312   a  configured for engaging the pole  294  and a second end  312   b  configured for engaging the pump  280  and/or mount  300 . Ideally, the second end  312   b  is configured to allow selective positioning of the pump  280  and/or mount  300 .  
      Turning now to  FIGS. 11A through 11C , there are shown front, top and end views, respectively, of the pump  280  attached to a pole  294 . Rather than the container  304 , a different feeding solution storage system is used. Attached to the pump  280  is a mount  320  which supports a container or reservoir  324  attached to the inlet tubing  268 . The reservoir  324  has a port  328  through which breast milk or other feeding solutions can be injected into the container. Additionally, the reservoir  324  may be collapsible, or may be vented to prevent the buildup of a vacuum within a container.  
      As noted above, one concern which is present with the administration of breast milk to a neonatal infant is that the breast milk will tend to separate if it is allowed to sit for too long. To limit the amount of separation, the reservoir  324  is configured so that it extends generally horizontally (i.e. the volume of milk contained therein is more horizontal than vertical). Additionally, a plurality of walls  332  can be disposed inside of the reservoir. Because of the relatively low height, the distance between any rising milk fats and sinking water containing proteins and sugars is kept fairly small. Additionally, the walls  332  encourage movement of all of the milk as it is being pumped to the neonatal infant, rather than simply milk immediately adjacent the inlet tubing  268 . To the extent that there is separation, the lateral movement of the milk out of the reservoir  324  tends to draw a blend of fats and water contained in the breast milk. If a container were simply hung in a conventional manner, the proteins and sugars would be delivered first, followed by milk fats which have risen to the top of the solution.  
      Turning now to  FIGS. 12A through 12C , there are shown front, top and end views of an alternate configuration of an embodiment of the invention. The enteral feeding pump  280  is attached to the IV pole  294 . While shown attached with a clamp  312 , it will be appreciated that the enteral feeding pump  280  can be attached with conventional attachment means, attached to a bed frame or simply placed on a table.  
      A mount  340  is attached to the enteral feeding pump  280 . Rather than being attached to the back side, as shown previously, the mount  340  is attached to the hinges  344  which enable opening and closing of the door  288 . Disposed on the mount  340  is a reservoir, such as the reservoir  324 . The position of the reservoir  324  above the pump provides easy access to the port  328  for injecting feeding solution. It also allows a health care worker to quickly view both the contents of the reservoir  324  and information provided by a screen  348  of the enteral feeding pump, such as the volume dispensed to the patient, the volumetric rate of delivery, etc.  
      Ideally, the mount  340  is configured so as to be sloped slightly toward the end where the reservoir  324  is connected to or formed integrally with the inlet tubing  268 . This encourages the breast milk or other feeding solution to work its way out of the reservoir  324  and into the tubing of the feeding set. Additionally, one advantage of having the mount  340  attached to the hinges  344  of the pump  280 , is that this allows reservoir  324  to be adjusted or to be rocked back and forth to minimize any separation. It also allows the milk to be disposed at an angle which is most convenient for viewing by medical personnel. It will be appreciated that the reservoir  324  can be collapsible or may include a vent to prevent vacuum pressure from interfering with solution delivery by the pump  280 .  
      While shown in conjunction with the ZEVEX ENTERALITE INFINITY enteral feeding pump, it will be appreciated that a variety of different pumps may be used in conjunction with various aspects of the present invention. One advantage of the present invention, however, is that it facilitates the use of less expensive enteral feeding pumps, while maintaining safety and control over the quantity and quality of the breast milk or other feeding solution which is being administered to the neonatal infant.  
      Turning now to  FIG. 13 , there is shown a side view of a reservoir  360  made in accordance with the principles of the present invention. The reservoir  360  has a port  364  for injecting breast milk or other feeding solution. In the alternative, the reservoir can have any variety of openings to allow the milk to be placed therein. Inside the reservoir  360  are a plurality of walls  368 . These walls  368  may be formed by radio frequency welding of the two sheets of thin walled plastic, as is customary in the art for disposable bag manufacturing. As the breast milk or other feeding solution is removed from the reservoir  360 , the milk flows around the walls. If the milk is allowed to hang for a prolonged period of time, the ability of the milk to separate is limited by the walls. Instead of the milk fat layer rising to the top of the container while the proteins and sugars sink to the bottom, the separation will tend to happen between adjacent pairs of walls. Thus, the distance between the top of the milk fat layer and the bottom of the watery proteins and sugars will be little more than the spacing of the walls. Thus, the milk delivered through the outlet port  372  to a neonatal infant will be more consistent.  
      Turning now to  FIG. 14 , there is shown a front view of an enteral feeding device similar to that shown in  FIG. 12A . Added to the mount  340  adjacent the hinges  344  is a motor unit  380 . The motor unit  380  may be powered by a electricity supply line  384 , may be powered by the pump  280 , or may be mechanically driven, such as by a winding mechanism and a spring. The function of the motor unit  380  is to cause the mount  340  to pivot with respect to the pump  280  to thereby shake the contents of the container  324 . This in turn, minimizes separation within the feeding solution, or between the mixture of feeding solution and medication, etc.  
      As was noted above, the separation of milk fats from the water and protein is generally not desirable. Additionally, the separation of medicine from the breast milk or other feeding solution is also undesirable. In some instances, a child&#39;s parent or the patient must wake periodically (as often as every hour or two) to shake a container of feeding solution to prevent a significantly uneven dose of medication being delivered to the patient. By providing a motor unit  380 , the solution can be moved to thereby minimize separation and minimize handling by the patient, parent, etc.  
       FIG. 15A  shows a cross-sectional view of an alternate configuration of a solution container  390 , designed to minimize separation within the enteral feeding solution prior to delivery to the patient. The container  390  includes a pair of protrusions  394  which act as mixing blades for a solution  398  disposed within the container. The protrusions  394  typically extend the length of the container  390 . As the container  390  rotates, the protrusions  394  mix the solution inside, thereby minimizing separation. The container  390  may be rotated completely, or may simply be rotated a set amount, i.e. 15-25 degrees, and then rotated in the opposite direction. Either way, the container  390  will minimize the separation within the feeding solution  398 . An outlet port  400  allows the solution  398  to be withdrawn from the container  390 .  
       FIG. 15B  shows a perspective view of the container  390 . Disposed at one end  390   a  of the container  390  is an outlet port side  400  through which the feeding solution is passed to an enteral feeding set. The container  390  shows four protrusions  394 , but any number of projections may be used as is necessary.  
       FIG. 15C  shows an end view of the solution container  390  disposed on a rocker motor  404 . The rocker motor  404  includes a housing  408  and a pair of supports  412  which are preferably elongate rotatable cylinders. One support  412   a  is preferably connected to a motor (either electric or mechanical) which rotates the support to thereby cause rotation of the container  390 . The rotation may be unidirectional, or may cause the container  390  to rotate back and forth some desired amount, i.e. between 15-25 degrees. Either way, the solution in the container  390  is mixed and separation is minimized.  
       FIG. 16A  shows a perspective view of an alternate configuration of a solution container  390  designed minimize separation within the feeding solution. The container  390  is shown with a plurality of baffles  424  for encouraging mixing. However, one skilled in the art will appreciate that baffles  424  are not required and that other structures could work as well. The container  390  is connected to the rotor  430  of a mixing mechanism  434  by a drive line  438 . The rotor of a peristaltic pump may be used as the mixing rotor  430 . As shown in  FIG. 16B , as the rotor  430  of the mixing mechanism  434  rotates, it acts on the drive line  438  to raise and lower the container  390 , thereby disturbing the contents of the container and causing the feeding solution, etc., to mix. It will be appreciated that the drive line  438  cause be modified to pivot a mount, such as that discussed above, or otherwise modified to agitate the container and cause mixing of the solution. A hinge may be used to pivotably attach the container  390  to the mixing mechanism  434 . It will also be appreciated that the container  390  will include a outlet port  400 , and it will be desirable to maintain the liquid around the outlet port so that air is not delivered to a patient.  
      Turning now to  FIG. 17A , there is shown a side view of a solution container  390  mounted by a clamp  444  to a pole  448 . The clamp  444  can include a motor unit  452  or other mechanism to cause the container  390  to pivot back and forth as shown in  FIGS. 17B, 17C  and  17 D. Thus the contents of the container  390  are periodically or continually shaken to minimize separation. An outlet port  442  is provided at the bottom of the container  390  to allow the liquid to flow out of the container and to a patient. This reduces the possibility of milk fats significantly separating from water and proteins, as well as minimizing the separation of the medication from the feeding solution. Thus, this aspect of the invention has applicability both to infants and to enteral feeding pump users of all ages who are concerned about fluid separation.  FIG. 17B  also shows protrusions  446  which may be formed along the bottom and/or sides of the container  390  to aid in the mixing of the liquid.  
       FIG. 18A  shows a close-up view of a static mixer  270 . The static mixer  270  can include a plurality of baffles  464  or other structures which agitate or otherwise mix the solution as it passes therethrough. Thus, in the present application applicant uses the term static mixer to refer to a mixer which utilizes one or more static elements to mix the fluid as the fluid flows through the mixer and past the static elements.  FIG. 18B  shows another static mixer  270  which includes one or more plates  472  having holes  476  formed therethrough. The static mixer is typically designed to provide a broken or tortuous path for the liquid to thereby cause mixing of the liquid as flow occurs. This causes the mixture, be it feeding solution or feeding solution and medication, to mix, thereby reducing separation. It will be appreciated that a combination of protrusions, baffles, plates, etc. may be used to create a desired flow path which mixes the liquid flowing therethrough. Those skilled in the art will appreciate that the design of the baffles or other structures to cause mixing can be selected to be particularly effective with solutions of the consistency of enteral feeding solutions. The static mixers described with reference to  FIGS. 18A and 18B  may be used in combination with any of the above embodiments of the invention.  
      There is thus disclosed an improved methods and apparatuses for controlled feeding of an infant. It will be appreciated that numerous changes may be made to the various embodiments of the present invention without departing from the scope of the claims. The appended claims are intended to cover such modifications.