Device For Performing A Tracheostomy And Other Surgical Procedures

Abstract

A device for aspiration, ventilation or visualization comprising: A. an expandable housing having an end portion tapered so as to form a means for puncturing, B. a plunger carrying a hollow tube, C. said tube and said plunger adapted to be inserted in said housing and movable with respect to said housing such that the depression of the plunger causes said tube to pass through and expand said tapered end portion of said housing.

Description

Tracheostomy is an operation, the origins of which are lost in antiquity. Such operations were described by the Egyptians and were well known in the age of Hypocrates. Its use in ancient times, in fact, until less than a quarter century ago, was reserved for relief of obstruction of respiratory passages. In this early period, tracheostomy was usually resorted to as a dramatic emergency procedure to relieve obstruction of larynx from dyptheria and occasionally from foreign body aspiration.

In sharp contrast, the current status of this operation is such that it is utilized much more frequently by any physician. The indication for its use has become legion and ill defined. Having become increasingly aware of the number of fatalities and major complications associated with this procedure, e.g., a major hospital has reported a mortality rate of 4.8 percent while the corresponding figure for appendectomy was 0.78 percent, Texas Medicine, September 1966, doctors have long sought a simple, safe device for performing a tracheostomy.

Heretofore, a tracheostomy was a major operation since it required a knife incision to the throat followed by insertion of a breathing tube. Such an incision usually results in extensive bleeding and with the insertion of the breathing tube, numerous complications may result. For example, following the opening of the anterior wall of the trachea, the posterior walls of the trachea may be inadvertently perforated, (1) by inserting the scalpel blade too deeply, (2) when the cartilage is being cut away from the anterior wall of the trachea, or (3) when the tracheostomy breathing tube is placed within the incision, if it is too rapidly and forcibly inserted through an opening. In addition, the tracheostomy tube may be inadvertently inserted adjacent to the trachea or into the superior mediastinum. Furthermore, traumatic pneumothorax may result from a tear in the parietal pleura caused by use of a retractor placed in the supra sternal notch or the improper insertion of the tracheostomy tube. Further dangers include hemorrhage, the formation of a tracheoesophageal fistula caused by injury to or perforation of the party wall of the trachea and esophagus and inadvertent severing or injury to the vocal cords.

The present invention provides a device for performing a tracheostomy which embraces all of the advantages of similarly employed devices, but none of the many disadvantages. The present invention is designed for use on-the-spot, wherever it is needed and may be used with relative safety by a surgeon, family doctor, or if necessitated by an emergency, a layman. To attain this, the present invention contemplates a unique device comprising both a needle arcuate cutting portion for making the initial incision, which portion then expands within the trachea wall, under the influence of a movable hollow tube contained within the confines of arcuate needle portion, to allow air to enter the passage. The device, when initially partially inserted into the trachea, has a relatively small diameter which is expanded after the initial insertion has been made to provide an adequate breathing opening for emergency purposes. Later on, at the hospital, a permanent breathing device would replace the emergency device.

The use of the present device avoids undue damage to the posterior wall of the trachea. In addition, the expansion of the initial opening provides an adequate breathing space, acts to stop bleeding along the sides of the opening, and also acts to hold the device in position. Furthermore, the initial opening need not be as large as was heretofore the case (generally a 1 to 2 inch cut) because cartilage and tough membranous portions of the neck area are easily expanded by the mechanical advantage afforded by this device. The needle cutting portion can be readily inserted to the proper depth by insertion and manipulation until an audible rush of air from the lungs is heard.

In addition to the use heretofore described, the present device may be used in a number of medical procedures wherein aspiration, ventilation or visualization is desired. Thus, for example, the device may be utilized in an open-window sinus operation to puncture the sinus cavity, expand the cartilege and drain the cavity. Likewise, the device may be used in a thorancentisis operation. Further, the device can be used in a venus puncture procedure to introduce a large tube into a vein. This is accomplished by first puncturing the vein with the needle portion of the device and second, introducing the hollow tube into the vein by depressing the plunger and thereafter inserting a flexible tube through the hollow tube into the vein for introduction of fluids, etc. In addition, in modified form, the device may be used either open or closed, with or without magnification, in visualization techniques which employ fiber optics. Further, the device, in slightly modified form, can be used to expand a collapsed lung by first essentially performing a tracheostomy and then forcing air or oxygen through an opening in the hollow tube in any convenient manner such as, for example, by breathing into the opening. This device could be used to breathe for drowning victims because air is gotten into the lungs much more efficiently than with mouth-to-mouth breathing, in that the so-called "dead space" in the throat is bypassed.

It is apparent from the foregoing that the present invention has a great many uses. However, for the purposes of the present application, only the preferred embodiment as a device for performing a tracheostomy will be described in detail.

Thus, the present invention may be described as a device comprising: a. an expandable housing, an end portion of said housing tapering so as to form a means for puncturing, b. a plunger carrying a hollow tube, c. said tube and said plunger adapted to be inserted in said housing and movable with respect to said housing such that the depression of said plunger causes said tube to pass through and expand said tapered end portion of said housing.

More particularly, the invention may be described as a device for performing a tracheostomy comprising: a. an expandable housing having an end portion adapted to be forcibly inserted into a trachea, b. a plunger carrying a hollow air tube, said plunger and said air tube adapted to be inserted in said housing and movable with respect to said housing such that the depression of said plunger will cause said air tube to pass through and expand said end portion of said housing by an amount equal to the outside diameter of said air tube.

FIG. 1 shows the inserted device and a connector tube leading to an oxygen supply;

FIG. 2 shows a partly sectional plan view of the device with the plunger in the retracted position;

FIG. 3 shows a partly sectional plan view of the device with the plunger in the depressed position with accessory for pumping air into the trachea;

FIG. 4 is a view taken in section on the plane 4,4 in FIG. 2 looking in the direction of the arrows;

FIG. 5 is a view taken in section on the plane 5,5 in FIG. 2, looking in the direction of the arrows;

FIG. 6 is a view taken in section on the plane 6,6 in FIG. 3, looking in the direction of the arrows; and

FIG. 7 is an exploded view of the device.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, where like reference characters designate like or corresponding parts throughout the several views, FIG. 7 illustrates an exploded view of the device comprising (1) a plunger 12 moveably mounted within (2) a conical housing 18. The housing 18 is provided with a needle-like cutting edge 32 for making the initial incision in the trachea. Under the influence of the forward movement of the plunger 12, within the housing 18, the cutting edge 32 being of a 2-piece construction, as will be described, expands and allows the plunger 12 to be positioned within the trachea. The plunger 12 is provided with an air passage and thereby, when properly positioned, allows air to enter the trachea.

More specifically, the plunger 12 is provided with an enlarged end portion 17. The end portion 17 is also provided with an elongated hollow air passage 13, passing longitudinally through its center. Air passage 13 promotes air exchange with hollow tube 24, the upper end portion of the tube 24 being fixedly connected into the lower end portion of plunger 12. Said upper end portion of tube 24 is truncated so as to form an elliptical cross-section and is seated in the lower end portion of plunger 12 such that the truncated portion rests adjacent to opening 26 further promoting air exchange. Likewise fenestrations 42 carried by said upper end portion of tube 24 also promote air exchange. A neck ring 14 is seated on flange 40 of the housing 18 and carries opening 19, as will be described. The overall length of tube 24 is such that when plunger 12 is in its fully depressed position, i.e., the enlarged end portion 17 of plunger 12 is positioned immediately adjacent to neck ring 14, the lower end portion of tube 24 will not extend substantially past the leading edge of arcuate cutting edge 32, as shown in FIG. 3. This is necessary so that potential damage to tissue that might be caused by inadvertent penetration of the posterior wall of the trachea by the lower end portion of tube 24 is avoided, when plunger 12 is in its fully depressed position.

Plunger 12 carrying tube 24 is designed to pass downwardly through opening 19 in neck ring 14. Opening 19 is of the same diameter as the elongated portion of plunger 12 and thus acts to guide plunger 12 in its movement within the housing 18. The lower end portion of plunger 12 carries a flange 15 which is of a width such that it will not pass through opening 19, thereby preventing plunger 12 from being inadvertently withdrawn from device 10. Neck ring 14 carries openings 30 which further promote air exchange. These openings may be on the side portions of neck ring 14 as well as on the top portion as shown in FIG. 7.

Neck ring 14 is fixedly connected to collar 22 in any convenient manner, e.g., adhesively. Collar 22 is designed to enable the operator to conveniently position the device by curling the second and third fingers, respectively, on the underside portions 23 and 25 of collar 22 as shown in FIG. 2. As further shown in FIG. 2, the operator's thumb is simultaneously placed on enlarged end portion 17 of plunger 12 for support and to enable the operator to apply a downward force on enlarged end portion 17.

The housing 18 preferably comprises two sections 18a, 18b forming a generally conical shape and having flanges 40a, 40b at its upper end. Collar 22 abuts the underside of flanges 40a, 40b and is retained, preferably by adhesive means, by the flanges. Collar 22 is provided with an interior annular space 21. A sealing O-ring 16 is press-fitted within said space and seals the upper end of the housing 18.

As mentioned, the lower end portions of housing 18 a, 18b terminate in an arcuate cutting edge 32 for making the initial incision in the trachea.

Upon depression of plunger 12 by the application of downward force to enlarged end portion 17, tube 24 is caused to pass through and expand the lower cutting end portions 35, 37 of housing 18a, 18b allowing air transfer to occur through tube 24 and fenestrations 42 with air openings 26, 28 and 30. Fenestrations 38 carried by the lower end portion of tube 24 function to prevent blockage of tube 24 by blood which may have leaked into tube 24, by allowing said blood to flow out of tube 24 into the space provided by housing 18a, 18b. O-ring 20 is circumferentially positioned generally about the lower end portion of housing 18a, 18b so as to maintain the configuration of arcuate cutting edge 32, during insertion of the cutting edge 32 into the trachea. The O-ring 20 also permits expansion of lower end portions 35 and 37 of housing 18 a, 18b upon the operation of the device. Housing 18a, 18b need not be comprised of two parts, but may be generally a single piece having an expandable lower end portion.

The device and its various parts, aside from the elastic O-rings, may be constructed of any rigid material such as plastic, e.g., polypropylene; metal or combination thereof, e.g., metal needle portion and plastic housing portion. The diameter of hollow tube 24 will depend on the use to which the device is put. Generally, it will have an inner diameter of from 3 to 6mm and preferrably 4 to 5mm. The gauge of arcuate cutting edge portion 32 also varies with the use of the device. In a tracheostomy, a 13 to 14 gauge is preferred.

To perform a tracheostomy, device 10 is held as shown in FIG. 2 with plunger 12 in its retracted position. Arcuate cutting edge 32 is then pushed into the trachea and manipulated until a rush of air is heard. The enlarged end portion 17 of plunger 12 is then depressed by the operator's thumb, his second and third fingers being positioned about the undersides 23 and 25 of collar 22 for support, thereby causing tube 24 to move downward through expandable housing 18a, 18b such that end portions 35 and 37 of housing 18a, 18b are caused to be expanded by an amount equal to the outer diameter of tube 24. This final resting position, as shown in FIG. 3, accomplishes several things. In the first place, the lower end portions 35 and 37 of housing 18a, 18b adjacent to the arcuate cutting edge 32 are pressed tightly against the inside edges of the wound caused by the initial puncturing of the skin. This pressure acts to prevent hemorrhaging. In addition, if arcuate cutting edge 32 is inserted in a cartilagenous or membranous portion of the neck, which is typically the case, the depression of plunger 12 causes tube 24 to expand the lower end portions 35 and 37 of housing 18a, 18b adjacent to arcuate cutting edge 32, overcoming any natural resistance of such tissue to be expanded. Small fenestrations 38 allow any blood which has seeped into the puncture area to be partially removed into housing 18a, 18b rather than possibly blocking tube 24. If fenestrations 38 are used in tube 24, then housing 18a, 18b should preferably be made of a transparent material so that blood leakage can be seen and attended to. Larger fenestrations 42 allow air exchange through openings 26, 28 and 30 to occur more readily.

FIG. 3 shows, additionally, adapter 34 connected to tube 36 which leads to an oxygen source. Adapter 34 carrying tube 36 may be connected into opening 28 if desired, after it is apparent that the tracheostomy has been successfully performed.

Claims

I claim:

1. A device for a surgical procedure comprising, in combination: a. a housing having an enlarged main portion and an end portion of a substantially smaller normal diameter than the average diameter of said enlarged main portion, said end portion comprising at least two sections which, taken together, taper to a cutting edge so as to form a means for puncturing human skin, means for holding said sections of said end portion together to form said cutting edge and to enable said sections of said end portion to be separable from each other and expand from said smaller normal diameter; and b. a hollow tube of smaller diameter than said enlarged main portion of said housing, said hollow tube being movable through said enlarged main portion of said housing, said hollow tube being of larger diameter than said normal diameter of said end portion whereby to expand said end portion outwardly from its normal diameter as said hollow tube is moved through said end portion.

2. A device as in claim 1 wherein the hollow tube is of a length such that when the plunger is in its full depressed position the lower end of said tube does not extend substantially below said end portion of said housing.

3. A device as in claim 1 wherein said hollow tube is carried on a plunger and said plunger has an air passage passing longitudinally through its center, and in air communication with said hollow tube.

4. A device as in claim 1 having means for introducing air into said air tube.

5. A device as in claim 1 wherein said end portion is an arcuate cutting edge.

6. A device for performing a tracheostomy comprising: a. a two piece, generally conical, expandable housing having an arcuate cutting end portion suitable for puncturing, said cutting end portion being held in position by a circumferentially displaced expandable ring; b. a plunger carrying a hollow air tube, said plunger and said air tube positioned in said housing by guiding means and movable with respect to said housing such that, following the puncturing of the anterior wall of the trachea with said cutting end portion, the depression of said plunger will cause the lower terminal end portion of said air tube to move from a first position wherein the diameter of said housing is larger than the outside diameter of said terminal end portion of said air tube to a second position wherein the diameter of the housing is smaller than the outside diameter of said terminal end portion of said air tube to thereby cause said housing, at said second position, to expand by an amount equal to the outside diameter of said terminal end portion of said air tube.

7. A device as in claim 6 wherein said second position is at the terminal end portion of said housing.

8. The device of claim 1 wherein said enlarged main portion of said housing is generally conical.

9. The device of claim 1 wherein said end portion of said housing is split so as to be expandable.