Surgery – Instruments – Oral pacifier
Reexamination Certificate
1999-11-08
2001-03-06
Buiz, Michael (Department: 3731)
Surgery
Instruments
Oral pacifier
Reexamination Certificate
active
06197044
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates generally to a device for administering oral fluids to infants and more particularly, to a pacifier adapted to facilitate the oral delivery of fluids to infants.
2. Related Art
Pacifiers are well known. Generally, pacifiers include a pliable nipple or teat which extends from one side of a guard or shield. The guard is usually contoured to comfortably fit against the area adjacent an infant's mouth. As suggested by the name, traditional pacifiers soothe or “pacify” an infant by providing an oral stimulation or distraction. Pacifiers also aid in the infants digestive and waste elimination processes, by stimulating salivation and peristalsis of the bowel. For these reasons, the use of a pacifier is generally desired and encouraged for both full term and prematurely born infants.
Of significance to the present invention are the special digestive needs of premature infants or “preemies.” Premature infants are generally defined as infants born after 36 weeks gestation or younger, and usually 2,000 grams or less. Due to their immaturity and diminutive stature, preemies are often incapable of bottle feeding or breast feeding for several weeks after birth.
Depending on the infant's age, weight, and development state, it may be necessary to initially feed the infant intravenously, using a Dextrose-based solution. Intravenous (IV) feeding is usually necessary until the child's digestive system has developed well enough to sufficiently absorb enough calories to support the infant's dynamic metabolism and at the same time promote growth and weight gain. An intermediate step between IV feeding and normal sucking and swallowing, is gavage tube feeding. This method involves supplying a milk-based formula or breast milk directly to the infant's stomach through a feeding tube which is threaded through the mouth and down the esophagus into the stomach. A bottle bag or syringe of formula is attached to the upper end of the gavage tube. Using the force of gravity, the formula slowly courses through the gavage tube directly into the infant's stomach. Gavage tube feeding is considered superior to IV feeding because it involves the normal digestion of a nutritionally complete formula, and is a natural step toward normal eating.
However, there are drawbacks to gavage tube feeding. For example, gavage tube feedings may tend to impede an infant's progression towards normal sucking and swallowing, since gavage tubes are deployed directly into the stomach of the infant. As a result, an infant's sucking muscles and swallowing reflexes are not exercised. Of course, sucking is important because it is the means by which an infant pulls liquid from a bottle or breast and because it encourages the production of saliva and digestive juices, which help digest the infant's food. Sucking also stimulates peristalsis of the bowel.
Unfortunately, if during a gavage feeding a caregiver wishes to provide an infant with a traditional pacifier, the gavage tube must first be removed. Some caregivers have attempted to rectify this problem by using the pacifier and gavage feeding tube simultaneously. For example, in U.S. Pat. No. 4,796,628 a pacifier is described for use simultaneously with a gavage feeding tube. The pacifier includes a nipple and a guard. The guard has a groove suitable for allowing the tube to be passed through the guard and into the infant's mouth. However, it is difficult for the infant to suck the traditional pacifier with the feeding tube in place because the tube passing down the side of the nipple of the pacifier interferes with a good seal on the pacifier and prevents proper and constructive sucking.
For these reasons, a pacifier is needed which accommodates gavage tube feedings and at the same time stimulates constructive sucking.
SUMMARY OF INVENTION
The present invention provides a device for administering oral fluids to infants. Specifically, the invention includes an improved pacifier configured to facilitate the oral delivery of fluids, such as formula and breast milk, to infants. The invention includes an improved pacifier, which may have a pliable nipple usually coupled to a mouth guard. The nipple typically extends outward from a surface of the mouth guard, such that the nipple can be inserted into an infant's mouth to encourage sucking. According to the principles of the present invention, the nipple has an inner lumen which may removably receive a tube, specifically a feeding or medication tube. The tube will generally serve as a passage way for oral fluids entering the digestive system of the infant. Thus, the improved pacifier allows a caregiver to administer medications or feedings without having to first remove the pacifier from the infant's mouth or else having to abstain from using the pacifier during the administration of medication or feedings altogether.
The improved pacifier may be used with the gavage tube feeding system. The pacifier can provide comfort to an infant while a tube from the gavage feeding system is passed through the lumen of the nipple into the infant's mouth and subsequently into the infant's throat and stomach. Since the tube enters the infant's mouth through the nipple lumen, the tube does not interfere with the infant's ability to create a good seal on the pacifier. Thus, the infant can receive the benefit of the feeding as well as the beneficial aspects provided by using the pacifier. While the pacifier is in the infant's mouth, the infant's tendency to suck the nipple encourages the infant to swallow. Swallowing during the insertion of the feeding tube helps to reduce the infant's tendency to gag, which makes it easier for a care provider to pass the tube through the throat.
Alternatively, a tube, such as a gavage feeding tube may already be in place in the infant's mouth when the caregiver decides to use the improved pacifier of the present invention. In this alternative example, the end of the feeding tube outside of the patient's mouth may be disconnected from the feeding source and threaded through the nipple lumen, such that the nipple can then be passed into the infant's mouth. The tube end may then be re-connected to the feeding source.
Advantageously, the improved pacifier may be used with other than a feeding tube system. For example, the improved pacifier may be used to administer medications through the tube, particularly viscous solutions, which may otherwise cause choking episodes, which lead to bradycardias. The improved pacifier may also be used to administer charcoal or barium through the tube, to minimize gastric aspiration, and it may be used either as a disposable or reusable unit.
In one aspect of the invention, an improved pacifier is provided which has a nipple and a mouth guard. The improvement includes a nipple which is formed with an inner lumen that extends from a first end to a second end of the nipple. The inner lumen has a first opening at the first end and a second opening at the second end. Thus, a tubular member may be removably received within the inner lumen through either opening. Advantageously, the tubular member includes a gavage feeding tube which may be coupled to a gavage container for the feeding of an infant. The gavage feeding tube may be selected from the group comprising any size tube, preferably a number 5 and/or a number 8 gavage tube.
In another aspect of the invention, an infant feeding system is provided which includes an infant pacifier. The infant pacifier includes a base; and a hollow nipple which is coupled to the base. The nipple has a first end, a second end, and an inner lumen extending from the first end to the second end. Each end of the lumen has an opening which is capable of removably receiving a tubular member. Advantageously, the gavage feeding tube and the infant pacifier can be used simultaneously and the infant pacifier can be inserted and removed from an infant's mouth without disturbing the tubu
Buiz Michael
Ho Tan-Uyen T.
Lopez Theodore P.
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