This invention relates to holding, centering and securely locking any medical tube inserted through a person's mouth by a medical pro essional. BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to an improved method of securely holding, centering and locking any medical tubes that must be inserted into a patients mouth by a Medical Professional. This invention with the addition of a properly designed pacifier for neonates and newborns and with the mouth piece for older children and adults can be used by hospitals everywhere. 2.Description of the Prior Art. When intubation is called for by a Doctor, the Doctor inserts the tube to the proper depth and then using hospital tape he tapes the tube to the patients face. Also a small balloon is sometimes inflated to help hold the tube in place. Another common method is to go through the nose with the tube. Sutures are another method used that go through the wall of the tube and are taped to the upper lip. Another method currently used is a molded dental plate. Tape has come loose and tubes have gone into the patients lungs. Also when the tape comes loose the tube is free to move up and down thus negating the use of the needed oxygen. The removal of the surgical tape bruises and is painful when removed. A number of medical problems have evolved when the tube goes through the nose. Older patients under trauma and stress have bitten through the tubes. The balloon has caused

permanent damage to the trachea. Neonates and other infants requiring oral intubation using the state of the art now in general practice have found that these babies develop many serious medical problems. MEDICAL HISTORY SHOWING THE NEED OF THIS INVENTION According to S.P. Ash,and J.P. Moss, they said, "Prolonged orotracheal intubation was shown to be associated with narrowing, deepening and some anterior elongation of the developing palate." 30 babies were used

-t - in this test of less than 32 weeks of gestation. They further stated, "However, it has been suggested that various dental anomalies may be the result of prolonged endotracheal intubation.

Saunders et al.(1976) reported two cases of palatal groove formation and Duke et al.(1976) reported two cases of acquired clefts of the hard palate. More recently Erenberg and Novae (1984), in a retrospective cross- sectional study found a 47.6 per cent incidence of palatal grooving in a group of pre-term infants subject to intubation...Even the use of "soft' endotracheal tubes does not lead to a reduction in the amount of palatal grooving (Molteni and Brumstead, 1986)." They went on to say, "It is common to find the babies sucking on the tube and this could result in a molding of the oral tissues and in particular the alveolus." They indicated that the evidence shows damage to the tooth buds.

"During reintubation, infants can suffer hypoxemia, bradycardia, and damage to the vocal cords (Thibeault, 1986)." "Death has occurred in some instances (Striker, Stool, & Downs,1967) (Freeman,1972) ."

An article by A~Delbert Bowen, M.D. reported on 18 cases of swallowed neonatal endotracheal tubes and one additional case of a 36 week gestation infant that swallowed the tube.

G. Ginoza, S. Cortez, and H.D. Modanlou, Stated, "Possible consequences of the acquired groove include problems with dentition, speech, hearing, and middle ear disease." They further determined from their study that 87.5* of infants that were intubated for 15 days had palatial grooving.

An article by G.M. Angelos, D.R. Smith, R. Jorgenson. and E.A. Sweeney confirms the problem of future dental problems when using neonatal oral tracheal intubation. Also another observation was made in this article that Sullivan (1982) describes that infants born after 26-36 weeks' gestation had neither sucking nor a coordinated swallowing reflex and had to be fed by nasogastric tubes. He suggested using orotracheal tubes for feeding if the tubes can be held securely. OBJECTIVES OF THE INVENTION

An object of the present invention is to provide a tube with a bellows in order to make 90 degree bends at the back of the throat without crimping. This will allow the tube to go straight back in the mouth and not curve against the soft or hard palate or press against the upper alveolar ridge.

An object of the invention is to give a baby a pacifier and to center the tube in the babies mouth. This will help to avoid the tube moving sideways or causing damage to the alveolar ridge.

An object of the invention is to fit the pacifier nipple to conform to the babies palate and tongue and to protect its mouth and tooth buds with a soft nipple. An object of the invention using the pacifier is to help the pre mature infants to develop its sucking and swallowing reflexes.

An object of the invention is to hold the tube securely so it can be used for an orogastric feeding

tube .

An object of the invention is to replace the nasogastric tube with the orogastric tube in order to prevent the medical problems that arise from feeding through the nose.

An object of the invention is to so lock and secure the tube so that it can not come loose and be swallowed or moved either in or out and to prevent accidental or spontaneous extubation. An object of the invention is a quick and easy method of installation. Once the tube is properly placed, our device is quickly threaded onto the tube and the proper depth is maintained by the lock and velcro tape.

An object of the invention is a quick and easy removal of lock, the face plate and the nipple or bite protector without disturbing the intubation.

An object of the invention is a face plate over the mouth in which the locking device is secured. This face plate acts as a restraining device for the tube and locks the pacifier and tube.

An object of the invention of the face plate is to allow access to the mouth through elongated holes in the face plate without having to remove the tube or disturb the intubation. An object of the invention is to hold the face plate, lock, pacifier or bite protector in place using velcro tape.

An object of the invention is to replace the strap and velcro tape easily and quickly without disturbing the intubation or face plate if and when the strap or velcro tape becomes contaminated

An object of the invention is a bite protector for the intubation of adults and older children and for locking, holding and centering the tube at the proper place.

An object of the invention is to hold and lock any tube required for any purpose that is inserted through the mouth.

Other objects and features of the present invention will be apparent to the user and the skilled Medical

Professional. To the accomplishment of the above objects, this invention may be embodied in the form illustrated in the accompanying drawings, attention being called to the fact, however, the drawings are illustrative only, and that changes may be made in the specific construction and design illustrated and described within the scope of the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig.l & 2 Shows the Velcro Tape, Face Plate, Nipple, Tube, Bellows, Collet and Nut. It illustrates the pacifier device.

Fig.3 Shows the Face plate.

Fig.4 Shows the split collet and nut.

Fig.5 Shows nipple detail. Fig.6 & 7 Shows the assembly with the pacifier.

Fig.8 & 9 Shows the assembly with the bite protector.

DETAILED DESCRIPTION OF THE DRAWINGS

No.l is the designed nipple.

No.l Fig.5 a. is rounded and elongated to fit the palate, b. is only slightly rounded for the tongue. The shoulder c is designed to go into the groove No.14 for securing the nipple to the device.

No.3 is the orotracheal tube or orogastric tube.

No.4 are the centimeter marks for depth of insertion calculations.

No.5 is a bellows design that will allow the tube to make turns without crimping and without curving to push against the hard palate, soft plate or the upper alveolar ridge.

No.7 is the face plate to hold the nipple and the locking device.

No.8 is the elongated holes for insertion of other things into the mouth when intubated. No.9 is a quick fastner for fastening and removing securely the strap and velcro tape to the face plate.

No.10 is for seating No.28 into the face plate.

No.11 is for locking No.12 into the face plate using

No.13 which is pressed into No.11 and can not be removed. No.14 is grooved to fit the shoulder of the nipple lc.

No.15 is the outside threads for nut No.22 and for inside threads No.24.

No.16 is the beveled shoulder for nut No.22 for bevel No.25, as the nut No.22 is tightened, No.25 closes the collet by pushing against the bevel. No.17 is the shaft for nut No.22.

No.18 is the ridge that holds nut No.22 on the shaft so that it can not be removed or lost.

No.19 is a bevel to allow tube No.3 easy and unobstructed entry through No.12.

No.20 is a hole slightly oversized again to allow tube No.3 easy and unobstructed access through No.12. No.21 is beveled and the hole is sized to the exact size of the tube being used. No.26 is the connector for the hospital device being used.

No.27 is the split collet that when nut No.22 is tightened it closes on the tube thus locking the tube in an unmovable position, but can't be overtightened because of slots in collet No.27. Yet when nut No.22 is loosened the device is easily removed without disturbing the intubation.

No.29 is the face plate with the bite protector No.31. No.30 is a rubber collar that is stretched over No.31 for

the teeth to rest or bite on.

No.32 shows the device fitted with the bite protector.

No.33 is the velcro tape for securing the device without using surgical tape.

No. 34 is a strap to which one side of the velcro tape is secured.