US 3659611 A
Improvement in tracheostomy and endotracheal tubes for effecting a substantial air seal between the tube and the trachea. There is provided on the periphery of the indwelling portion of the device a series of thin resilient, circular flanges, of silicone rubber, for example. The flanges bend for insertion and withdrawal and engage the wall of the trachea to form an air seal therewith.
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Description (OCR text may contain errors)
United States Patent [1s] 3,659,61 1 Miller May 2, 1972 54] TRACHEAL TUBE SEAL 2,185,927 1/1940 Shelanski ..12s/245 x 3,322,126 5/1967 Riisch et al..  Kansas 3,516,410 6/1970 Hakim ..12s/350 R  Assignee: Dow Corning Corporation, Midland, Mich.
Primary Examiner-Channing L. Pace  Flled' 1969 Attorney-Robert F. Fleming, Jr., Laurence R. Hobey, Harry [21} Appl. No.: 884,869 D. Dingman and Howard W. Hermann 52 Us. or. .......12s/ss1, 128/245  ABSTRACT Cl 1 25/02 A61!" 3/00 improvement in tracheostomy and endotracheal tubes for ef- Field Search "123/349 R1 245i fecting a substantial air seal between the tube and the trachea. 285/1 10 There is provided on the periphery of the indwelling portion of the device a series of thin resilient, circular flanges, of silicone  Rfl'rences cued rubber, for example. The flanges bend for insertion and UNITED STATES FATENTS withdrawal and engage the wall of the trachea to form an air seal therewith. 724,913 4/1903 Montgomery 128/245 UX 1,383,502 7/ 192! Vultee ..l28/245 5 Claims, 2 Drawing Figures Pnhntod May 2, 1972 Q 3,659,611
I 1' v INVENTOR' I 1 DON R. MILLER I rromvir TRACHEAL TUBE SEAL BACKGROUND OF THE INVENTION The present invention relates to the field of surgical appliances and more particularly, to improvements in tracheal tube assemblies.
Tracheal tubes are utilized for administration of general anesthesia and in situations wherein the normal respiratory functions have been impaired. It is quite common in the latter event for the use of a surgical procedure termed tracheostomy; that is, for an incision to be made in the throat and a tracheal tube assembly inserted through the opening and into the trachea. This procedure allows communication between the trachea, or windpipe, and the ambient air so that the impaired areas of the nose or throat are bypassed in the respiratory function.
It is a fairly common practice to provide an inflatable cuff on the distal end of tracheal tube devices. The cuff is designed to be inflated by means of a tube connected to a pumping device outside the patient's body in order to effect an air seal between the tracheal .tube'and the trachea. There have been numerous instances in which the pressure in the cuff exerted over a large area of the trachea has been found to be a causative agent in the production of tracheal injury. Furthermore, it is difficult. to manufacture inflatable cuffs from materials which are most particularly suited for use within the human body such as silicone rubber.
SUMMARY OF THE INVENTION The primary object of the present invention therefore is to provide an improved tracheal tube structure which will be free from the aforementioned, and other, disadvantages of prior devices of this type.
More articularly, it is an object of the present invention to provide a tracheal tube device which eliminates insofar as possible the danger of production of tracheal injury.
It is still a further object of the present invention to provide a structure which is easily and inexpensively manufactured.
In accordance with these and other objects, there is provided by the present invention a novel system for replacing the inflatable cuff formerly used on such devices. According to the preferred embodiments of the invention, a plurality of thin circular discs of resilient material are mounted substantially at right angles to the distal end of the tube. The discs are made extremely thin so that they are easily bent while the tube is being inserted, but due to their resiliency expand to fill the area between the tube and the wall of the trachea thereby forming an air seal in this area. These discs are preferably of silicone rubber material and act as occluders to air passing between the tube and the trachea but because of their very thin construction, exert substantially no pressure against the tracheal wall. The discs can be simply molded onto the device or molded separately and affixed to the device by means of suitable adhesives which are readily available. Accordingly, the construction of the device is extremely simple when compared to the construction of cuffed tracheal devices which have been used heretofore.
BRIEF DESCRIPTION OF THE DRAWINGS Other objects and attendant advantages of the invention will become obvious to those skilled in the art by reading the following detailed description in connection with the accompanying drawings wherein:
FIG. 1 is a view in perspective of a preferred embodiment of the invention;
FIG. 2 is a partial cross-section showing the operation of the device in the trachea of the patient.
DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawings wherein like reference characters designate like or corresponding parts throughout the figures thereof, there is shown in FIG. 1 a tracheostomy tube comprising'a limiting flange 11 mounted substantially perpendicularly to a curved tubular portion 12 extending from the flange to the distal end 13 of the device. The flange is preferably molded with a pair of slots '14 and 16 for attachment to the throat of the patient by means of straps, for example. The. proximal end of the device may be equipped with a suitable collar and male connecting part 17 for attachment by means of a hose to external equipment if desired. Thus far, the tube as described is conventional in the art and other variations may be employed without departing from the scope or spirit of the invention.
In any case, according to the invention, the distal portion of the tube is provided with a series of thin, solid, resilient disclike flanges 18, 19, 21 preferably attached to the tubular portion 12 in spaced parallel relationship perpendicular to the axis of the tubular portion. In a preferred embodiment, these disc-like flanges were made of silicone, rubber and were made 0.5 mm. in thickness. The spacing between adjacent flanges was 5mm. and the distance between the most distal flange 21 and the distal termination of the tubular portion 13 was 3 cm. Each of the discs was circular and 22 mm. in diameter.
Preferably, the devices are made in a series of sizes designed to accommodate the physical size of the trachea of the patient into whom the device is to be inserted. For average adult males, it has been found that the diameter of the trachea averages approximately 20 mm. in diameter and for females, the diameter varies between about 16 and [9 mm. The flange diameter should be slightly larger than the tracheal diameter to insure occlusion.
The number of discs on the tube may vary. In some instances, one disc is sufficient. However, it is preferred that two or three discs be supplied to insure a good seal. The thickness of the disc, of course, may also be varied somewhat depending upon the flexibility of the material used to form the disc. The disc, of course, must have sufficient rigidity. The disc should not be so stiff as to cause tissue trauma, either during insertion or while in place in the trachea. While the discs have been described as circular, it should be realized that slightly elliptical shapes and other shapes can also be used. Also, while it is preferred that thediscs be mounted at right angles to the axis of the tubular portion, some variation in angle is possible without negating the function of the device.
Referring now to FIG. 2, the device is shown in place in the trachea 22 of a patient. The embodiment shown in this figure includes three discs, each bearing circumferentially around the tracheal wall. The flange I3 bears against the skin on the surface of the throat and the tubular portion 12 extends into the trachea. A hose 23 is shown attached to the male portion 17 of the proximal end of the device.
While the invention has been specifically described with reference to tracheostomy tubes, it is to be understood that it can be applied equally well to endotracheal devices which are designed for insertion through the mouth or nose. The device is easily manufactured by either molding the discs integral with the tubular portion or molding the discs separately and securing them in place on the tubular portion by means of a suitable adhesive. The device exhibits a minimum of tissue trauma and is effective in operation.
Obviously, other modifications and variations of the invention will become obvious to those skilled in the art. Accordingly, the invention may be practiced otherwise than as specifically described.
That which is claimed is:
1. In a tracheal tube comprising a proximal end of the device and an elongated tubular portion extending from said proximal end to the distal end of the device, said tubular portion being designed for insertion into the trachea, the improvement which comprises:
at least one, thin, solid, resilient disc-like flange around the periphery of said tubular portion, said flange having a diameter slightly larger than the normal diameter of the tracheal lumen so that when the tubular portion is inserted into a trachea the flange will be deformed to con- 4. The improvement as defined in claim 1 wherein a plurality of said flanges are mounted in spaced parallel relationship perpendicular to the axis of said tubular portion near its distal end.
5. The improvement as defined in claim 4 wherein said flanges are silicone rubber.
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