Abstract:
A nursing device for feeding infants with a cleft lip and/or cleft palate includes a nipple body and a tube operatively attached at one end to a pump for pumping liquid and operatively attached at the other end to the nipple body. The tube passively regulates the amount of liquid being pumped, ensuring that the infant can feed with minimal mess from the infirmities of cleft lip and/or cleft palate. The nipple body includes an outer flange and a cap for sealing engagement with the top of a nursing bottle. A shield can be used to cover the nipple body, which serves to protect and form a temporary reservoir for the liquid dispensed through the nipple body.

Description:
CROSS REFERENCE TO RELATED PATENT APPLICATION 
     This application is a continuation-in-part of U.S. patent application Ser. No. 11/370,045 filed on Mar. 8, 2006. 
    
    
     FIELD OF THE INVENTION 
     This invention relates generally to a nursing device, and more particularly to a nursing bottle for infants with a cleft lip and/or cleft palate. 
     BACKGROUND OF THE INVENTION 
     Cleft lips and cleft palates are common birth defects and require special attention during the initial six months of a child&#39;s life. To be more specific, there are three types of cleft lip, i.e., unilateral incomplete, unilateral complete and bilateral complete. There are also three types of cleft palates, namely the soft palate only, the unilateral complete, and the bilateral complete. However, each of the cleft lip and/or cleft palate malformations involves leakage of air from the mouth through the nose, which causes an infant to be unable to suck, causing regurgitation of fluids through the nose and difficulty in swallowing and breathing. 
     For a period of about six months until the infant has matured enough for corrective surgery, the infant must be fed. Feeding is not only the most immediate problem encountered in the daily care of an infant with a cleft lip and/or cleft palate, but it is one of the more difficult to solve and the most necessary for the survival of the child. 
     A U.S. Pat. No. 4,856,663 of Epp discloses a nursing device for infants with a cleft lip or cleft palate. As disclosed, the device comprises a solid duckbill shaped shield with an incorporated nipple on its underside, together with means for interconnecting the nipple and a baby bottle or breast. The shield acts to seal the cleft palate, while keeping the nipple from collapsing into the cleft palate and cleft lip to allow an infant to suck liquids from a bottle or the breast. 
     A French Patent No. 2,622,102 A1 of Michel Grateau discloses a control device with feedback for artificial feeding systems for force-feeding of infants. The device, which is fitted into a nursing bottle, allows a caregiver to control the feeding device. 
     A more recent U.S. Pat. No. 6,033,367 of Goldfield discloses a smart bottle and system for neonatal nursing. The system for diagnosing or monitoring sucking/swallowing/breathing of an impaired neonate includes a processor for receiving a signal from a breath sensor. The system develops an output for intraoral tactical or flow control feedback. In a feeding or monitoring embodiment the processor applies a signal to control a liquid feeding valve, which supplies nutrients through a feeding nipple. In another embodiment, adapted for manual feeding, the processor displays a waveform indicative of the breath or airflow sensor output, and a manually operated pressure bulb is provided to allow a nurse to apply arrhythmic muscular pressure stimulus via a feeding or surrogate nipple in a manner visually synchronized with the displayed breath activity. 
     Notwithstanding the above, it is presently believed that there is a need for and a commercial potential for an improved feeding device in accordance with the present invention. There should be a demand for such devices because the devices pump measured amounts of milk in pre-selected periods of time to overcome the difficulties in feeding children with cleft lips and cleft palates. Further, the devices in accordance with the invention include a nipple so that a baby can develop an ability to suck and at the same time to exercise and massage the muscles of the face. In some cases, a baby cannot cope with swallowing because of the defect in the palate. However, with the devices in accordance with the present invention, a nurse or mother can pump measured amounts of nutrient so that the child obtains enough nutrients in enough time without adversely affecting their general condition. 
     The devices in accordance with the present invention are also applicable for pre-natal infants, i.e., those born before 32 weeks. The suction reflex in such infants may not be fully developed and the child may choke on nutrient from an ordinary bottle. Such choking may lead to infection. Further, the use of the present invention may allow the infant to leave the hospital at an earlier time since the mother will be able to feed the child at home. Another advantage of the device is that it has a nipple that helps in developing a child&#39;s ability to suck. 
     Further, children with special needs that have a problem with swallowing may also benefit from the use of the devices in accordance with the invention. Still further, the devices avoid a problem associated with spilling relatively large amounts of milk during feeding. Also, such devices can be used to feed fluid foods to elderly people who are having feeding problems. 
     SUMMARY OF THE INVENTION 
     In essence, the present invention contemplates a nursing device or baby&#39;s bottle for feeding infants with a cleft lip or cleft palate. The nursing device includes an upper portion including a bottle for containing a supply of nutrients and/or water with an opening at one end thereof. The upper portion also includes a nipple and means for maintaining the nipple in sealing engagement with the top of the bottle. In a preferred embodiment of the invention, the top of the bottle includes a threaded neck portion around the opening and is adapted to receive a conventional cap thereon. The cap includes a central opening adapted to receive a nipple therein and internal threads for engaging the external threads on the bottle. Thus, tightening the cap squeezes a flange on the outer portion of the nipple between the top of the bottle and the underside of the cap to form a liquid tight seal. A pump is disposed in the bottle below the surface of the liquid nutrient or water and preferably near or on the bottom of the bottle. Tubular means, such as a flexible hose or semi-rigid or rigid conduit, connects an output of the pump with a forward portion of the nipple for delivering pre-selected amounts of nutrients or water through the nipple and into an infant&#39;s mouth. A lower portion of the device includes a housing and a motor disposed in the housing for rotating the pump through a magnetic coupling. An important feature of the present invention resides in means, such as a timer, for regulating the amount of nutrient or water pumped in a given period of time. The timer may also include means for regulating the cycle. 
     Other embodiments comprise an attachment that secures removably to the threaded neck of a conventional nursing bottle or the like. The attachment has a base that threads onto the neck of the bottle, and a substantially sealed housing that contains an electric motor and controls and electrical storage battery power for the motor. 
     One embodiment includes the motor driven pump within the housing. The pump preferably is a peristaltic pump having a rotary device that travels along the outer surface of a length of flexible tube to compress the tube progressively and force liquid through the tube. Thus, the only liquid path through the housing comprises an unbroken length of flexible tubing extending through the floor of the housing and through the pump to the nipple extending from the top of the housing to minimize the possibility of leakage within the housing. 
     Another embodiment places the pump below the floor of the housing. The pump has a magnetic rotor that is driven by a magnetic drive from the motor in order to preclude the need for a passage through the floor for a driveshaft. Again, the only liquid path through the housing comprises a tube extending from the pump through the floor of the housing and out the top of the housing to the nipple extending therefrom. 
     The top of the housing is configured for the threaded attachment of a conventional nursing bottle cap thereto. The cap serves to capture the base flange of a nursing bottle nipple between the top of the housing and the inwardly disposed flange of the cap. Single or double nipples having the output end of the tube extending therethrough may be provided with any of the embodiments disclosed herein. The nursing bottle is preferably conventional, and may have a neck disposed coaxially with the bottle or aligned at some angle to the bottle. 
     The invention will now be described in connection with the following drawings wherein like reference numerals have been used to define like parts. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side elevational view of a prior art nursing bottle for children with cleft lips and/or cleft palates. 
         FIG. 2  is a cross-sectional view of a nursing bottle in accordance with the present invention. 
         FIG. 3  is a schematic illustration of a programmable timer for use in the present invention. 
         FIG. 4  is a cross-sectional view of a nursing bottle with a feed regulating nipple according to a second embodiment of the invention. 
         FIG. 5  is an environmental perspective view of a third embodiment of a nursing device according to the present invention, comprising a nursing bottle and attachment being used to feed an infant. 
         FIG. 6  is a partial side elevation view in section of the nursing device of  FIG. 5 , showing attachment of a metered liquid dispensing device having a feed regulating nipple to a conventional nursing. 
         FIG. 7  is a partial side elevation view in section of a fourth embodiment of a nursing device according to the present invention, showing a metered liquid dispensing device having a feed regulating nipple attached to a nursing bottle having an angularly displaced. 
         FIG. 8  is a partial perspective view of the nursing device of  FIG. 6 , showing an exemplary external control array. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     A prior art baby bottle for feeding children with a cleft lip and/or a cleft palate is shown in  FIG. 1 . As shown, a conventional baby&#39;s bottle  2  includes an elongated container  4  having an open end with an external thread (not shown) formed thereon. A conventional cap  6  has an opening therein and an internal threaded portion and a nipple  8  extends therethrough as attached to the top of the bottle in a conventional manner. However, the nipple  8  includes a substantially solid thin shield  10  of latex rubber or the like. The shield  10  is designed and constructed to prevent the nipple from collapsing into a cleft palate. 
     A nursing bottle  20  in accordance with the present invention includes an upper section  22  having an elongated bottle  24 , which is shaped like a conventional baby&#39;s bottle and made of glass or suitable plastic material. Like conventional bottles, the elongated bottles are preferably clear or translucent so that a caregiver can monitor the amount of nutrient being dispensed. The bottle  24  also includes an opening  25  in an upper portion thereof, and a threaded neck  26  surrounds the opening  25 . The threaded neck  26  is constructed and dimensioned to receive a threaded cap  28  with a nipple  30  extending through an opening in the cap  28  in a conventional manner. As in a conventional baby&#39;s bottle, the nipple  30  includes a peripheral flange at a base thereof. This flange is compressed between a top of the cap  28  and top of the neck  26 . 
     Unlike a conventional baby&#39;s bottle, the nursing device  20  includes an elongated tubular member  34 , which passes through the nipple from a forward opening for delivering liquid, such as milk or water, to an infant. The tubular member may be flexible, semi-flexible or relatively rigid and of a suitable plastic material and is connected to a small submersible rotary pump for delivering pre-selected amounts of liquid to an infant. 
     A small rotatable submersible pump  36 , the output of which is connected to the tube  34 , is disposed in the bottom of the bottle  24 . The pump  36  is connected to a motor  38  through a magnetic coupling  40  (shown schematically). The motor  38  is disposed in a lower section  42  of the device. 
     The lower section  42  includes a plastic housing  44 , which is attached to the bottom of the bottle  24  in any conventional manner. A programmable timer  46  of conventional design regulates the motor  38  in order to provide a selected volume of liquid to an infant and may be programmed to provide small amounts of liquid with intermittent pauses to provide a more natural feeding. A battery  48  is disposed in the lower section  42  for powering the motor  38  and includes means  50  for connecting the batteries to an external charger  52 , which is connected to a source of electricity in a conventional manner. 
     The programmable timer  46  is shown schematically in  FIG. 3  and typically includes a microprocessor to control the programming, which is well within the ability of a person of ordinary skill in the art. The timer  46  is also of conventional design and regulates the volume of liquid pumped and the length of pauses between pumping for each feeding cycle. The volume of liquid may be adjusted by a knob  51  and the timing for a pause by a knob  53 . An LED display  55  may also be provided as an indication of volume. For example, the height or amplitude may be shown on the display, or the pause may be indicated by ½ wavelength. 
     A further embodiment of the invention, which is similar to the first embodiment, is illustrated in  FIG. 4 . The difference is that the nipple  30  shown in  FIG. 2  is replaced with a nipple  60  having a soft rubber shield  62  for covering the defect of the baby&#39;s mouth to thereby prevent leakage of milk due to a cleft lip or cleft palate. 
     In the embodiments of  FIGS. 2-4 , the tube  34  can be integral with the opening in the feed regulating nipple  30 , or a can be a separate member detachably mounted thereto. The tube  34  facilitates delivery of the nutritious liquid in a controlled manner that will not tax an infant&#39;s ability to provide the necessary suction and/or seal, especially infants suffering from cleft lip or cleft palate. This regulation of liquid delivery occurs because only a certain amount of liquid can pass through the tube for any given amount of pressure. Unlike conventional nipples used in infant bottles, any suction or biting of the conventional nipple causes a relative torrent or large amount of liquid to be dispensed. This frequently leads to waste and soiling of the infant&#39;s clothes and face due to the infant&#39;s inability to swallow such quantities at once. The nipple  30  has a circular flange and a hollow liquid delivery protrusion extending from the flange, an orifice defined in the tip end of the protrusion, and the tube  34  extending from the orifice so that the only milk that can be dispensed through the orifice must pass through the tube  34 . In contrast to conventional nipples, the tube  34  regulates and controls the stream of milk through the orifice by forcing the liquid to be indirectly delivered through the tube  34 , rather than directly through the nipple opening or orifice in conventional nipples, and the quantity being delivered thereby is much smaller and manageable for consumption by infants. The liquid is pumped by the pump  36  described above. However, the nipple  30  can be used to deliver liquid via manual means, e.g., squeezing the bottle or through the efforts of the feeding infant. In this instance, the length of the tube  34  can be shortened so that the intake opening of the tube  34  lies near the top of the bottle during use, since any infant bottle would normally be tilted up during use and the intake opening should be disposed near the bottom of the accumulated liquid inside the bottle at that angle. 
       FIGS. 5 through 8  of the drawings illustrate two additional embodiments of the nursing device having a metered liquid dispensing device. The metered liquid dispensing device has a bottle attachment housing having the motor, pump, and controls enclosed in or mounted on the housing, which is removably threaded in place atop the bottle by means of the conventional externally threaded neck of the bottle. The primary difference between the two embodiments of  FIGS. 5-8  is the location of the pump. One embodiment has the pump located within the housing, and the other embodiment has the pump located below the housing and extending into the upper volume of the bottle to which the housing is attached. 
       FIG. 6  provides a detailed side elevation view in section of an embodiment of a nursing device having a metered liquid dispensing device  110  that has all of the components of the dispensing device  110  contained within or mounted on a bottle attachment housing  112 . Each of the various components within the housing  112 , which is illustrated schematically in  FIG. 6 , is conventionally available. The bottle attachment housing  112  has an internally threaded bottle attachment base  114 . A floor  116  extends across the housing  112  immediately above the threaded base  114 . The threaded base  114  is adapted for attachment to the externally threaded neck of a standard baby bottle, e.g., the bottle B 1  of  FIGS. 5 ,  6 , and  8 , or alternatively, to the angled neck of the bottle  132  shown in  FIG. 7 . The bottles B 1  and B 2 , or other bottle having an externally threaded neck, may be formed of transparent or translucent glass or plastic material to enable the caregiver to check the contents of the bottle visually. 
     The opposite upper end of the housing  112  has an externally threaded nipple attachment top  118  having a cover  120  spanning the upper end of the top  118  at the upper limit of the threads. The externally threaded nipple attachment top  118  of the housing  112  is of the same diameter and thread pitch as a conventional baby bottle, e.g., the bottle B 1 . Thus, it is adapted to accept an internally threaded nipple collar or cap C conventionally used to capture the flange of the nipple N thereunder to secure it to the neck of the bottle B 1 . The bottle attachment housing  112  defines a substantially sealed interior volume  122  (with the exception of two small passages for the feeding tube, and additional lateral passages for access to controls for the device) for the containment of the operative components of the metering device  110 . 
     The interior  122  of the housing  112  contains a liquid pump  124  that communicates with the interior volume V 1  of the bottle  131  by means of a liquid flow inlet passage  126  formed through the floor  116  of the housing  112 . The pump  124  is preferably a conventional peristaltic pump, i.e., a continuous liquid delivery line or tube  128  is sealed at or through the inlet passage  126  and extends through the pump  124  and through a delivery line or tube outlet passage  130  through the cover  120  of the housing  112  to extend through the perforated tip or orifice of the nipple N. The pump  124  includes one or more rollers therein that travel along a portion of the flexible tube or line  128  disposed within the liquid pump  124  housing, progressively compressing the wall of the tube  128  to convey liquid therethrough. However, other types of pumps may be used in the metering device  110 , if desired. 
     The liquid pump  124  is selectively driven by an electric motor  132  that receives its power from a power supply  134 , comprising a preferably rechargeable electrical storage cell or battery pack disposed within the housing  112 . A recharging port  136  may be provided through the wall of the housing  112 . A control system  138  communicates electrically with the motor  132  and/or power supply  134  to control the power delivered to the motor  132  by the power supply  134 , thereby controlling the speed, operating time, pause time, and/or other factors relating to the operation of the liquid pump  124  and its delivery of liquid from the bottle B 1 . Input to the control system  138  is provided by one or more external control passages  140  disposed through the sidewall of the housing  112 . 
       FIG. 8  provides a perspective view of the metered liquid dispensing device  110  of  FIG. 6 , illustrating an exemplary configuration of its external controls and display. The natural sucking action of a normal infant results in a series of liquid pulses entering the mouth of the infant. The pause between pulses provides time for the infant to swallow. However, an infant with a cleft lip or palate is incapable of producing the suction required to draw the liquid from the bottle without assistance. Accordingly, the present nursing device in its various embodiments provides a pump to deliver positive liquid flow from the nipple of the bottle in a series of intermittent pulses simulating the natural sucking reflex of an infant and giving the infant time to swallow after each pulse. The controls for the metering device  110  include a volume control  142  that allows the caregiver to adjust the rate of flow or volume of each pulse of liquid delivered, and a pause tinier control  144  to adjust the time between each pulse of liquid. A display  146  is provided to enable the caregiver to visually determine the magnitude of each pulse of liquid, the duration of the pulses, and the time interval between pulses. The controls  142  and  144  and the display  146  are conventional, such controls and display being well known in the art of microcomputerized pump controls. 
       FIG. 7  of the drawings provides a side elevation view in section of an alternative embodiment of the metered liquid dispensing device, designated as metering device  210 . The metering device  110  comprises a bottle attachment housing  212  having a configuration similar to the bottle attachment housing  112  illustrated in detail in  FIG. 6 , i.e., having an internally threaded bottle attachment base  214  that has a floor  216  extending across the housing  212  immediately above the threaded base  214  adapted for attachment to the conventional externally threaded neck of a standard baby bottle, e.g., the angled neck of the bottle B 2  shown in  FIG. 7 , or alternatively, to the straight neck of the bottle B 1 , illustrated in  FIGS. 5 ,  6 , and  8 . 
     The opposite upper end of the bottle attachment housing  212  has an externally threaded nipple attachment top  218  having a cover  220  spanning the upper end of the top  218  at the upper limit of the threads. The externally threaded nipple attachment top  218  of the housing  212  is of the same diameter and thread pitch as a conventional baby bottle, e.g., the bottle B 2  in order to accept a conventional internally threaded nipple attachment collar or cap C to capture the flange of the nipple thereunder and secure the nipple to the neck of the bottle B 2 . However, the embodiment illustrated in  FIG. 7  includes an inner nipple IN having a nipple flange NF captured between the nipple attachment cap C (or more precisely, beneath the overlying shield flange SF that is, in turn, captured beneath the cap C) and the underlying nipple attachment top  218  (and the outer portion of the cover  220  formed integrally with the top  218 ). The metering device  210  also includes an outer shield S over the inner nipple IN. The shield S has a shield flange SF captured between the overlying nipple attachment cap C and the nipple attachment top  218  and cover  220 , or more precisely between the cap C and the underlying inner nipple flange IF. The shield S serves to prevent the collapse of the relatively soft inner nipple N. The shield S also serves as a temporary reservoir where discreet amounts of liquid can accumulate for subsequent consumption by the infant. The shield S also has an orifice defined in its tip end for delivery of milk or other liquids from the baby bottle to the infant. 
     The bottle attachment housing  212  defines a substantially sealed interior volume  222  (with the exception of two small passages for the feeding tube, and additional lateral passages for access to controls for the device) for the containment and mounting of the operative components of the device  210 . The metered liquid dispensing device  210  differs from the metering device  110  in that the liquid pump  224  is disposed external to the housing  212  and below the floor  216 , so that the pump  224  is within the interior volume V 2  of the bottle B 2  when the metering device  210  is installed thereon. The pump  224  is preferably a peristaltic pump, as described further above in the discussion of the metering device  110  of  FIG. 6 . A passage  226  is provided through the floor  216  of the housing  212 , and a liquid delivery line or tube  228  extends from the pump  224  through the passage  226  in the floor  216 , through the interior of the housing  212  and through the delivery line tube outlet passage  230  in the cover  220  of the housing  212 . The delivery line or tube  228  extends at least through the perforated tip of the inner nipple IN, and terminates in the space between the inner nipple IN and the outer shield S in the metering device  210  of  FIG. 7 . However, the delivery line  228  may be extended to the perforated tip of the shield S, if desired. 
     The pump  224  is selectively driven by an electric motor  232  that is disposed within the interior volume  222  of the housing  212 , i.e., on the opposite side of the floor  216  from the pump  224 . No passage for a driveshaft between the motor  232  and the pump  224  is provided, in order to minimize the number of passages and corresponding potential leaks through the floor  216 . Rather, a magnetic drive  225  is provided between the motor  232  and the pump  224 . The drive utilizes a magnet with a rotating polarity driven by the motor  232 . A corresponding magnet or ferromagnetic component at the pump  224  is driven by the rotation of the drive magnet. Such magnetic drives are conventional, and are well known in the field of small motor drive systems. 
     The motor  232  receives its power from a power supply  234 , comprising a preferably rechargeable electrical storage cell or battery pack disposed within the housing  212 . A recharging port  236  may be provided through the wall of the housing  212 . A control system  238  communicates electrically with the motor  232  and/or power supply  234  to control the power delivered to the motor  232  by the power supply  234 , thereby controlling the speed, operating time, pause time, and/or other factors relating to the operation of the liquid pump  224  and its delivery of liquid from the bottle B 2 . Input to the control system  238  is provided by one or more external control passages  240  disposed through the sidewall of the housing  212 . The external appearance of the control system of the metered liquid dispensing device  210  may be substantially similar to the control system illustrated in  FIGS. 5 and 8 . 
     It will be seen that many of the various components of the various embodiments illustrated in  FIGS. 5 through 8  are interchangeable with one another, e.g., the metered liquid dispensing device embodiment  110  may be installed upon either bottle type B 1  or B 2 , or other suitable bottle configuration as desired. Moreover, the inner nipple IN and shield S may be used in the nursing device of  FIG. 6 , if desired. The external appearance of the metered liquid dispensing device in the embodiments of  FIGS. 5 through 8  is unobtrusive, thus enabling the caregiver of an infant requiring such a device to use the device without attracting undue attention. This provides much greater comfort and peace of mind to the caregiver, and further encourages the caregiver to enter social situations and expose the infant thereto without concern that the action of bottle feeding the infant will be seen as other than a normal or usual procedure. 
     While the invention has been described in connection with its preferred embodiments, it should be recognized that changes and modifications may be made herein without departing from the scope of the appended claims.