Patent Application
20150164270
The present invention pertains generally to a sanitary bag system for heating liquids in a hospital setting. More particularly, the present invention pertains to sanitary bag systems for heating neonate nutritional liquids such as mother's milk or prepared formula. The present invention is particularly, but not exclusively, useful as a disposable sanitary bag system for use with a warmer having a heated, warming well for the purpose of warming a nutritional liquid prior to administering the liquid to a neonate.
Nutritional fluids for neonates (i.e. infants less than about 4 weeks old) must be served at the proper temperature and must be free of harmful bacteria. As is well known, such fluids include prepared formula as well as preserved mother's milk. In any event, the optimal serving temperature is about 97° F.; close to the temperature that breast milk is delivered directly by a mother. Since this temperature is 27° Fahrenheit above room temperature, the nutritional fluids must typically be warmed before they are administered to the neonate. During warming of the fluid, care must be taken to avoid overheating the fluid. In fact, temperatures over about 100° F. can kill enzymes, proteins, blood cells and many other components of breast milk. These temperatures can also cause destruction of other nutritional fluids. In this regard, heating techniques that rely on radiation and/or convective heat transfer tend to heat the fluid in a non-uniform and possibly dangerous manner. This can cause harm to the neonate due to burns or other tissue destruction due to the mistreatment of the nutritional fluid. This non-uniform heating can often result in hot spots (i.e. portions of the fluid that are overheated), resulting in the destruction of important fluid components.
One technique for uniformly heating a container of nutritional liquid involves placing the container in the warming well of a warmer. For this process, the use of a conductive fluid, such as water in the well, can be used to improve heat transfer and promote uniform heating. In addition, vibration of the well can be used to improve heat transfer and promote uniform heating. However, when containers are loosely placed within the well, vibration can cause the container of nutritional liquid to move within the well. In some cases, this undesirable movement is sufficient to cause the container of nutritional liquid to move to a position within the well where uniform heating no longer occurs.
While handling the nutritional fluid, and during the warming process, it is important to ensure that bacteria is not introduced into the nutritional fluid. This is because exposure of a neonate to certain types of bacteria can cause adverse complications. One such adverse complication, necrotizing enterocolitis (NEC) occurs in about 3%-7% of all infants in neonatal intensive care units. This percentage of NEC increases as the birth weight of the neonate decreases. In more detail, NEC is an inflammatory gastrointestinal (GI) disease which causes tissue necrosis in the GI tract. Unfortunately, a large percentage of neonates that contract NEC die of the disease (in one study an NEC morbidity rate exceeding 25 percent was found).
As described above, oftentimes water is introduced into a warming well of a warmer to facilitate uniform heating of a container of nutritional fluid. In some cases, this water is obtained at a hospital faucet, sometimes sterilized in a hospital setting, and introduced into bags or containers by hospital personnel, such as nurses. Unfortunately, these procedures are time-consuming, often result in the introduction of contaminates into the warming process and waste valuable hospital resources. On the other hand, the present invention recognizes that it is more efficient to sterilize and permanently seal a warming fluid in a pouch at a remote, sterile processing facility, rather than attempt to produce a sterile water-filled pouch in an often contaminated hospital environment.
In light of the above, it is an object of the present invention to provide a disposable system, and corresponding method of use, for safely and uniformly warming a neonate nutritional fluid while minimizing the introduction of harmful bacteria into the warming process. Another object of the present invention is to provide a disposable bag system that holds a container of neonate nutritional fluid in place within a warming well of a warmer during vibration of the warming well to ensure that uniform heating occurs. Yet another object of the present invention is to provide a disposable, ready-to-use system for warming a neonate nutritional fluid in a warming well that uses conductive heat transfer to avoid overheating the fluid. Still another object of the present invention is to provide a sanitary bag system for warming a neonate nutritional liquid that is easy to use and comparatively cost effective.
In accordance with the present invention, a disposable system for use in warming a neonate nutritional liquid includes a pouch and a liner. The pouch includes a first flexible bag, a second flexible bag and a rigid connecting component. To establish the pouch, the two flexible bags are arranged as an inner and outer bag and are coupled to each other to establish a permanently sealed compartment between the bags. For the present invention, at least one of the bags is attached to the connecting component. With this arrangement, the pouch extends from a closed first end at the connecting component to a second, open pouch end.
Also for the present invention, a thermally conductive fluid is disposed within the compartment that is established by the pouch. For example, the thermally conductive fluid may be a sanitized gel type substance or it may be a liquid, such as sanitized water. As detailed further below, this cooperation of structure allows heat to flow from the outside of the pouch to a neonate nutritional liquid that is disposed within the pouch.
In addition to the pouch, the disposable system includes a liner having a flexible bag and a rigid connector component. For the system, one end of the liner bag is attached to the connector component and the other end of the liner bag is open to receive a container of neonate nutritional liquid.
To assemble the pouch and liner together, the connector component of the liner is first inserted into the pouch. Then, the connector component of the liner is engaged with the connecting component of the pouch to removably attach the liner to the pouch. With this arrangement, a liner can be removed from a pouch and replaced with a new liner. For the disposable system, it is envisioned that the pouch will have a useful life of about one (1) week while the less expensive liners will be replaced after about twelve (12) hours of use or about four neonatal feedings. With this in mind, a typical kit for the disposable system can include a sealed package having a single pouch and a plurality, e.g. ten or more liners, all sterilized and ready for immediate use.
In one embodiment of the disposable system, the rigid connecting component of the pouch comprises an annular ring that surrounds a recess. For use with the ring, the rigid connector component of the liner can be formed as a disk or as a ring. To establish the attachment, either the pouch connecting component or the liner connector component is formed with a tang and the other is formed with a groove. The groove is sized to receive the tang and snap the connecting component and connector component together. For example, the disk and ring can be made of plastic. In another embodiment, a two piece snap fastener similar to the snap fasteners used in clothing can be used as the pouch connecting component and the liner connector component to removably attach the liner to the pouch.
For the disposable system, the flexible bag portion of the liner can include a mechanical seal that is located adjacent the open end of bag. With this structure, a seal can be established to selectively enclose the container of neonate nutritional liquid inside the liner during a warming procedure. In one embodiment, the mechanical seal is a ridge-into-groove connector, sometimes referred to as a so-called ‘zip-lock’ or ‘plastic zipper’ type seal. In another embodiment, the mechanical seal can include an adhesive that is positioned along at least 50% of a periphery of the liner flexible bag, with the adhesive being positioned to avoid a remainder portion of the periphery. For this embodiment, the disposable system can also include a protective cover that is positioned over the adhesive for selective removal therefrom to allow the adhesive to adhere to the remainder portion.
In another aspect of the present invention, an apparatus for warming a neonate nutritional liquid includes a warmer and the disposable system having a pouch and liner as described above. For the apparatus, the warmer includes a warming well having a closed first end and an open second end. The warmer includes at least one heating coil to heat the warming well which is typically made of a heat resistant material such as a metal or ceramic. A temperature sensor, such as a thermistor, can be positioned at the bottom of the warming well and the warmer can include a means for vibrating the warming well.
To use the apparatus, a container, such as a syringe, of neonate nutritional liquid is inserted into the liner and sealed. Next, the connector component of the liner is inserted into the pouch and engaged with the connecting component of the pouch. With this attachment, the assembly is placed within a warming well of the warmer. Next, the warming well is heated and vibrated. During this process, heat from the warming well passes through the conductive fluid in the pouch and through the thin flexible liner to the neonate nutritional liquid, to warm the neonate nutritional liquid in a uniform, controllable manner.
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:
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Cross referencing
It is to be appreciated that in alternate embodiments (not shown) the tang 38, 38′ can be formed on the connecting component 20, 20′ of the pouch 12, 12′ and the corresponding groove 40, 40′ can be formed on the connector component 32, 32′ of the liner 14, 14′.
Returning now to
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While the particular sanitary bag system for warming a neonate nutritional liquid, and corresponding methods of assembly and use, as herein shown and disclosed in detail are fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that they are 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.
