Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas
Reexamination Certificate
2001-03-14
2004-08-17
Bennett, Henry (Department: 3743)
Surgery
Respiratory method or device
Means for mixing treating agent with respiratory gas
C128S204180, C128S200260, C606S234000, C606S236000
Reexamination Certificate
active
06776157
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a medical pacifier and method for use thereof in providing anesthesia and other gases to pediatric patients.
2. Background Art
Induction of general anesthesia in infants and young children is most commonly accomplished by inhalation of anesthetic gases via the respiratory tract. In addition, the use of inhaled medications is often used for the treatment of pediatric patients with asthma and other illnesses.
For induction of anesthesia, the gas delivery system usually comprises a plastic or rubber face mask sized to cover a child's nose and mouth. Application of the face mask is unfamiliar and fear-inducing for the child, and most children to experience a smothering sensation. The resulting anxiety causes a child to struggle, hold his breath, and scream or cry. In addition, children also object to the smell of the anesthetic agent. Unfortunately, once the child is distressed, administration of anesthesia becomes much more difficult. Consequently, the infant or child usually requires preoperative sedative medicine to quiet him or her before the anesthesiologist is able to approach the child with the face mask.
Many children will suck vigorously at the edge of a standard face mask as the anesthesiologist attempts to cover the child's nose and mouth. While such suckling instinctively quiets and calms a child, it will often prevent the face mask from being properly positioned on the child's face. This, in turn, prevents a tight seal from being formed around of the edge of the mask, such that a significant amount of anesthetic gas may potentially leak from the mask and induction of anesthesia is slowed. Therefore, the mask must often be continuously pressed against the child's face by a medical practitioner in order to maintain sealed contact during administration of the anesthesia.
Due to a child's innate propensity to suckle, many pediatric anesthesiologists have resorted to giving a pacifier to the child prior to induction of anesthesia. In fact, children accustomed to a pacifier will often be anesthetized using a face mask secured over the child's nose and mouth with the pacifier in place. However, such a procedure usually requires the anesthesiologist to use a larger face mask, which increases the difficulty of maintaining a tight fit of the mask to the face. A larger mask size also increases the dead space inside the mask, which can lead to respiratory complications due to the inhalation of expired carbon dioxide.
Due to these difficulties, medical pacifiers have been developed which are capable of delivering anesthesia or other gases without use of a standard face mask. For example, U.S. Pat. No. 5,904,140 discloses a pacifier which includes a body having an inlet connected to a nebulizer for receiving air-entrained medication, and a closed end mounted to a stopper which carries a nipple. The body includes a discharge port over which a deflector is mounted. In operation, the air-entrained medication exits the pacifier body through the discharge port and is directed by the deflector toward the nostrils of an infant sucking on the nipple. As another example, U.S. Pat. No. 5,375,593 discloses a pacifier having a housing, a nipple connected to the housing, and a pair of nasal cannulae which extend out of the housing and are connected to an external oxygen source. The cannulae are positioned such that they are directed into the nostrils for discharging gas when the pacifier is placed in an infant's mouth.
While pacifiers such as those described above overcome some of the problems associated with standard anesthesia face masks, additional problems are introduced due to their method of operation. First, since the devices do not form a seal around the nostrils and merely direct anesthetic gas toward the nostrils, an unacceptable amount of anesthetic gas may be dispersed into the room air. Second, anesthesia and other gases inhaled via the nasal passages are naturally filtered, thereby reducing the amount of gas which reaches the lungs of the patient over a given time. This may result in a longer time required for inhalation therapy to be performed, and possibly less consistent and less efficacious outcomes.
SUMMARY OF THE INVENTION
Therefore, it is an object according to the present invention to provide a medical pacifier and method for use thereof which provide improved comfort and efficiency during induction of anesthesia and other gases.
It is a further object according to the present invention to provide a medical pacifier and method for use thereof wherein induction of anesthesia and other gases is accomplished via the oral cavity.
It is another object according to the present invention to provide a medical pacifier and method for use thereof which are readily accepted by pediatric patients.
It is still another object according to the present invention to provide a medical pacifier that is simple and inexpensive to manufacture.
Accordingly, a medical pacifier for delivering anesthesia and other gases into the oral cavity of a patient, such as an infant or child, is provided. The pacifier includes a nipple member adapted to be received within an oral cavity of the patient, the nipple member having a conduit extending therethrough and an outlet opening provided therein. A base is attached to the nipple member and adapted to remain outside the oral cavity. The base includes an inlet opening provided therein and a lumen extending therethrough which is in fluid communication with the conduit of the nipple member. The inlet opening is adapted to be connected to an external gas source such that gas can flow through the base and the nipple member for delivery via the outlet opening into the oral cavity of the patient.
The pacifier is preferably molded from a plastic material and is of one-piece construction. The base includes a base plate disposed generally perpendicular to a longitudinal axis of the nipple member, where the base plate includes a concave front surface facing the nipple member, and a convex rear surface facing away from the nipple member. The base further includes a connector projecting from the rear surface of the base plate, where the lumen extends through the connector and the inlet opening is disposed in a proximal end of the connector. Preferably, the outlet opening is provided in a distal end of the nipple member, and a handle ring is preferably pivotally attached to the rear surface of the base plate.
The proximal end of the connector preferably has an outer diameter of approximately 15 mm to provide compatible attachment to a standard external breathing tube. In one embodiment, the connector is generally L-shaped, and the pacifier includes a longitudinal slit formed therein for receiving an endoscope. In addition, the nipple member can be impregnated with medication to be dispensed to the patient.
In further accordance with the present invention, an apparatus for inducing anesthesia in patient is provided. The apparatus includes a breathing circuit including a source of anesthetic gas and an inlet tube connected to the source and operable to transport the gas toward the patient. The apparatus further includes a medical pacifier connected to the breathing circuit. The pacifier includes a nipple member adapted to be received within an oral cavity of the patient, the nipple member having a conduit extending therethrough and an outlet opening provided therein. A base is attached to the nipple member and adapted to remain outside the oral cavity. The base includes an inlet opening provided therein and a lumen extending therethrough which is in fluid communication with the conduit of the nipple member. The inlet opening is adapted to be connected to the inlet tube such that anesthetic gas can flow through the base and the nipple member for delivery via the outlet opening into the oral cavity of the patient.
Correspondingly, a method for delivering anesthesia or other gases to a patient is provided. The method includes inserting a medical pacifier into an
Huntington John H.
Williams Kayode A.
Bennett Henry
Brooks & Kushman P.C.
Patel Mital
The Regents of the University of Michigan
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