Surgery – Instruments – Oral pacifier
Reexamination Certificate
2000-11-07
2002-09-24
Reip, David O. (Department: 3731)
Surgery
Instruments
Oral pacifier
C606S236000
Reexamination Certificate
active
06454788
ABSTRACT:
BACKGROUND OF THE INVENTION
1. The Field of the Invention
Pertains generally to the apparatus and method of use of modified infant oral pacification devices for administering liquids and medications to infants and young children. More specifically, the present invention solves the problem of how to gently administer fluids orally in a near continuous or continuous fashion to provide an effective and non-traumatic method and apparatus for treating dehydration.
2. Description of the Prior Art
Gastroenteritis leading to dehydration is a common medical problem faced by infants, young children and their parents. The major goal in treating and preventing dehydration during gastroenteritis is to maintain adequate fluid hydration. The three main methods of administering rehydrating fluids are oral, intravenous and nasogastric methods. Obviously, intravenous and nasogastric methods of administering fluids are invasive, traumatic, require specialized training to administer, and are difficult to provide at home. Oral administration of fluids is the preferred mode of dehydration treatment; however, this mode often fails because it is labor intensive and requires a near continuous administration of fluid. For example, most infants less than 2 years old require about 24 ounces of liquid per day, which equates to a rate of consumption of approximately 1 ounce per hour. During a bout of gastroenteritis, many infants and young children can not tolerate drinking an ounce of fluid at a time without vomiting. In such cases, a slow and steady administration of oral fluids is most successfull when given orally at a rate of approximately 0.5 cc/min to 1.5 cc/min, which is administered in small amounts of 0.5 cc or less at a time, dosed every 1 to 3 minutes, using a syringe or a spoon. Invariately, most patients with gastroenteritis are thirsty, so a typical sick infant or child would eagerly and aggressively gulp down fluid to quench his thirst, only to vomit because of an upset stomach. Unfortunately, many parents allow the sick infant or child to drink ad lib from a bottle or cup which predisposes the sick infant or child to begin a cycle of gulping and vomiting. This self-defeating cycle of gulping and vomiting repeats itself until the sick infant becomes too dehydrated to drink. Furthermore, the care giver frequently becomes frustrated and stressed by this cycle of drinking and vomiting and may even erroneously withhold fluids from the dehydrated infant. Therefore, there is a need for a simple device which is easy to operate and which can help parents administer oral fluids to their children in a controlled fashion to optimize the likelihood of success when treating gastroenteritis at home.
The prior art teaches that pacifiers, made for non-nutritive sucking, may be modified to be used by care givers to administer liquid medications and fluids; however, the prior art devices suffer many shortcomings. U.S. Pat. Nos. 3,610,248 and 5,601,605 typify the prior art fluid administering pacifiers. These devices consist of a hollow nipple, a nipple shield, and a small compressible reservoir. Fluid is placed in the reservoir and the pacifier is placed in the infant's mouth, then the infant either sucks the fluid out of the reservoir as in U.S. Pat. No. 3,610,248, or a care giver may compress the reservoir and force the fluid into the infant's mouth. One shortcoming of these devices is a small reservoir, so the device has to be repeatably removed from the infant's mouth and refilled. Understandably, removing the pacifier device repeatedly from the infant's mouth to refill agitates the infant and may promote irritability and vomiting. Another shortcoming of the prior art device, is that the nipple holes administer fluid preferentially to the back of the throat, which risks activating the gag reflex and induce vomiting, especially when the care giver forces fluid from the reservoir into the infant's mouth. Other patents, to include U.S. Patents Des 377,830, Des 391,642, Des 380,270, and Des 335,187, all show variations of the general prior art design, and all share the disadvantage that the device must be removed from the infant's mouth to refill. In addition, all of the prior art devices, except for U.S. Patent Des 377,830, have no way for the care giver to control the rate of flow of liquids to the infant. Lastly, the prior art devices deliver fluid into the back of the throat, thereby risking gagging the patient, instead of administering fluid preferentially to the natural physiologic gutters found lateral to the tongue in the oral cavity. These natural gutters are designed to drain saliva and fluids from the oral cavity to the pharynx and esophagus and are at a relatively low risk for accidentally triggering vomiting.
Therefore, there is a need for a modified pacifier for administering medications and rehydration fluids that has a conveniently refillable reservoir, and which delivers fluids preferentially towards the physiologic gutters of the oral cavity.
SUMMARY OF THE INVENTION
It is a primary object of the invention to overcome the shortcomings of the prior art infant pacifier devices for use by an operator for administering fluids and medications.
It is a primary object of the invention to provide an infant pacification device for the gentle administration of oral rehydration fluids in a near continuous or continuous fashion.
It is a primary object of the invention to provide an infant pacification device that can be used to administer oral medications.
It is a primary object of the invention to provide a pacification device for infants.
It is a primary object of the invention to provide a pacification device for the gentle administration of fluids and medications utilizing a detachable, conveniently refillable reservoir that minimizes infant agitation.
It is a primary object of the invention to provide a pacification device for the gentle administration of fluids and liquid medications to infants and young children that minimizes the risk of gagging by preferentially directing fluids and liquid medications to the lateral physiologic gutters of the oral cavity.
It is a primary object of the invention to overcome the limitations of the prior art pacifier devices by providing a pacifier apparatus including an attachable access assembly, a nipple portion having an array of terminal ducts with corresponding holes, a shield, and an attachable and readily refillable reservoir.
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Shevlov, S.P. (Ed): Caring for Your Baby and Young Child: Birth to Age 5. Bantam Books, New York, May 1991, pp. 491-493.
Shevlov, S.P. (Ed): Caring for Your Baby and Young Child: Birth to Age 5. Bantam Books, New York, May 1991, pp. 491-493.
Ashton Wesley Scott
Woo Julian W.
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