Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
2002-04-04
2004-07-13
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S200260
Reexamination Certificate
active
06761171
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention generally relates to endotracheal tubes, and more particularly, to endotracheal tubes having a bendable portion designed to facilitate intubation of difficult airways (tracheal inlet opening) caused by anatomical variation, trauma and the like.
2. General Background and State of the Art
An endotracheal tube generally comprises a cylindrical tube used as an air passage to administer oxygen and anesthetic gases directly to the patient. The cylindrical tube terminates in an open distal end configured for insertion into the trachea and has an opposite open proximal end configured to be coupled to a gas source. The endotracheal tube typically has an inflatable cuff on the exterior of the cylindrical tube for forming a seal with the interior walls of the trachea. (See U.S. Pat. No. 3,460,541 to Doherty). The cuff functions to occlude the trachea which protects the trachea and lungs against aspiration of foreign substances. In particular, food, foreign bodies or digestive system contents are prevented from entering the lungs. The endotracheal tube is used primarily in surgery, but is also frequently used in emergency rooms and emergency in-the-field situations.
In surgical procedures requiring general anesthesia, the patient is rendered unconscious by administration of anesthetic agents including drugs and/or gases. The patient is also given a muscle relaxant/paralyzing agent to minimize the patient's gagging response to the insertion of the endotracheal tube. A laryngoscope is placed in the mouth of the patient. The blade portion of the laryngoscope is used to push the tongue laterally and the intubating practitioner applies a lifting force to the laryngoscope handle in order to visualize the anatomical structures of the mouth and airway. A specific target area of the tracheal tube is the glottis, which is the opening between the vocal cords and the inlet to the trachea. The distal end of the endotracheal tube is inserted into the glottis and the inflatable cuff (balloon) is filled with air to create an airtight seal between the cuff walls and the interior walls of the trachea. This airtight seal allows for delivery of the oxygen and anesthetic gases with positive pressure directly to the air passages below the tip and the balloon.
Patient anatomies differ greatly and fall into specific categories that are grouped according to potential difficulty of tube insertion. In a patient with an anterior glottis or target orifice (the vocal cords and opening positioned high in the patient's neck and to the front of the neck), placing the insertion end of the endotracheal tube through the opening can be extremely difficult, and can lead to serious injury and even death from lack of oxygen. Although careful evaluation by the anesthesiologist or healthcare practitioner may suggest difficulty, the condition is usually undetectable until the orifice and vocal cords are visualized with a laryngoscope and blade apparatus. When this occurs, the practitioner must remove the laryngoscope, and the insert a metal or plastic stylette (semi-rigid wire) into the lumen of the endotracheal tube, bend the tube and stylette into an appropriate configuration to aid in placing the insertion tip in its proper location and to act as a placement guide. A small bend, resembling the shape of a hockey stick, is made in the stylette and the end of the endotracheal tube, while the main body of the tube remains unchanged. Once this is accomplished, another attempt is made by the practitioner to visualize the vocal cords and inlet. The bent shape of the insertion tip improves the chances of passing the tip through the tracheal orifice. An example of early endotracheal tube including a stylette for curvature is described in U.S. Pat. No. 2,458,305 to Sanders.
Although this method of using a stylette to bend the insertion end of the endotracheal is widely used, it has many shortcomings. The steps of bending the tube in the correct configuration, subsequent visualizing the path of insertion, and then removing the stylette from the lumen of the endotracheal tube wastes valuable time in completing the intubation procedure. Time is of the utmost importance in an unconscious patient who is not breathing, particularly where the patient may have a full stomach with an increased chance for aspiration of foreign substance.
Also, the use of a stylette is usually employed after an initial attempt has been made with the laryngoscope in place. Further, because of there intended use stylettes must be semi-rigid, capable of being easily bent and, once bent, and shape retaining. This inherent characteristic places a patient at risk of an injury from the stylette to the airway with potential for bleeding in the airway as well. In the past, puncture of soft tissue and vocal cord damage has been attributed to the use of stylettes.
None of the prior devices have succeeded in the elimination of the use of a stylette to properly configure an endotracheal tube and successfully intubate a patient.
Many devices have been designed to assist in the placement of the tracheal tube in the target orifice. For example, laryngoscopes have been developed to aid in insertion. However, these devices do not provide any mechanism for controlling the curvature of the insertion end of the endotracheal tube itself.
U.S. Pat. No. 4,589,410 to Miller, U.S. Pat. No. 4,150,676 to Jackson and U.S. Pat. No. 4,685,457 to Donenfeld each show an endotracheal tube with at least one pull cord in the wall along a portion of the length of the tube. Applying tension on the cord causes the tube at a position proximal to the balloon to curl, apparently due to the compressibility of the material of construction. However, the tip of the tube does not bend, the bending being distributed along the whole length of the pull cord. These devices do not employ a hinge or spring-type mechanism or altered tube wall, nor do they use a locking device. As a result, these prior devices do not allow selected movement at the tip of the tube. In these prior devices, the body of the tube is moved by a pulley mechanism which bends a considerable portion of the tube, thus creating problems due movement of the tube within the mouth.
Other devices employing tube bending mechanism include U.S. Pat. No. 5,255,668 to Umeda is directed to a bendable endoscope used for broncoscopy which includes a bendable distal portion spaced between two coils in the wall of the tube, the bendable portion is caused to bend by pulling on a wire in the wall of the tube. U.S. Pat. No. 4,911,148 to Sosnowski et al. is directed to small diameter (diameter of 0.15 mm or less) endoscopes which have a series of radial notches spaced along the length of the tube and a pull wire through the notched wall. Pulling on the wire causes the tube to bend along the portion containing the notches, which in turn causes the tip to deflect. U.S. Pat. No. 5,304,131 to Paskar shows an arterial or venous catheter with an area of weakness along one side of the catheter. The weakness is the result of gaps cut through the wall of the catheter. Bending of the weakened portion is provided by a wire running through the wall on the side of the gaps. To aid in returning the weakened portion to its original straight orientation that portion may be surrounded by a spring and, to seal the weakened portion, a jacket can cover the spring and the weakened portion.
U.S. Pat. No. 4,353,358 to Emerson is directed to a flexible sigmoidoscope which has notches and a pull wire similar to Sosnowski et al. Other flexible tipped endoscopes and catheters with hinged portions and a pull wire are also shown in U.S. Pat. No. 5,772,578 to Heimberger, et al. and U.S. Pat. No. 5,448,989 to Heckele. U.S. Pat. No. 5,306,245 to Heaven shows a bendable tubular device which includes a cutaway wall opposite a flexible stainless steel hinge with a pull wire in the tube wall opposite to the hinge. At least the cut-out portion is covered by an outer plastic material. This plastic cover may also cover the p
Kotin Jay S
Toti Andrew J.
Wong Michael H.
Lewis Aaron J.
Mitchell Teena
Tachner Leonard
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