Cook Incorporated

Other

Cook Medical Technologies LLC

Pasquale Ciaglia

Joseph P Lane

Mark J Hiatt

Melodee Deckard

Frank J Fischer, Jr

A dilator () for creating tracheostomies in one pass. Dilator () includes a generally linear shaft () extending from a proximal end () and beginning at a distance therefrom, gradually and continuously through a curved distal portion () of continuously decreasing diameter (from about 38 french) to a distal tip portion () of small diameter of about 12 french at distal end (). The outer surface of the insertable portion is treated or hydrophilically coated to minimize friction, and the gradual taper gradually widens the tracheal entrance opening () between tracheal rings () with minimal trauma. The wall thickness gradually decreases from the linear shaft () to the soft distal tip portion (). The continuing curve of the distal portion () enables the increasingly longer inserted portion of the dilator to remain situated in the trachea () during insertion and for the distal tip portion to clear the posterior tracheal wall.

Percutaneous dilational device

A dilator ( ) for creating tracheostomies in one pass. Dilator ( ) includes a generally linear shaft ( ) extending from a proximal end ( ) and beginning at a distance therefrom, gradually and continuously through a curved distal portion ( ) of continuously decreasing diameter (from about 38 french) to a distal tip portion ( ) of small diameter of about 12 french at distal end ( ). The outer surface of the insertable portion is treated or hydrophilically coated to minimize friction, and the gradual taper gradually widens the tracheal entrance opening ( ) between tracheal rings ( ) with minimal trauma. The wall thickness gradually decreases from the linear shaft ( ) to the soft distal tip portion ( ). The continuing curve of the distal portion ( ) enables the increasingly longer inserted portion of the dilator to remain situated in the trachea ( ) during insertion and for the distal tip portion to clear the posterior tracheal wall.

A method and device 10 for providing an ostomy 102 through the wall 100 of the trachea are particularly advantageous in allowing the ostomy 102 to be formed atraumatically and to be enlarged without risk of perforating the rear of the trachea. The method employs a balloon catheter 16 including an inflatable balloon 18 and entails: positioning the catheter 16 over a percutaneously inserted wire guide 54; advancing the catheter 16 along the wire guide 54 until the balloon 18 lies across the tracheal wall 100; and inflating the balloon 18 to dilate a portion of the tracheal wall 100 and form an ostomy 102. The method desirably includes the further steps of deflating the balloon 18 and inserting a tracheal tube 20 into the ostomy 102. The method is preferably carried out with a device 10 which includes a dilator tube 12 carrying the catheter 16 and tracheal tube 20 on it. Such a construction allows the dilator tube 12, the balloon catheter 16 and the tracheal tube 20 to be advanced on the wire guide 54 together. The tracheal tube 20 can include an inflatable circumferential cuff 24 for providing a seal between the tracheal tube 20 and the tracheal wall 100. The diameter of the balloon 18 preferably is at least equal to, and more preferably slightly greater than, the maximum diameter of the uninflated cuff 24 to be inserted into the ostomy 102. The present invention is also advantageous in that the close dilation or slight over dilation of the ostomy 102 and the taper of the distal end 14 of the dilator tube 12 protect the cuff 24 from damage during insertion of the tracheal tube 20 through the ostomy 102.

Percutaneous balloon dilational tracheostomy tube

A speculum for forming an ostomy in a trachea. The speculum includes a pair of opposing, pivotally interconnected elongated members and respective distal nose portions extending distally from the elongated members. The elongated members have respective proximal handle portions of which the distal nose portions extend laterally therefrom. One of the nose portions includes a tubular member with a flexible distal end that has a preformed curve and extends distally beyond the other nose portion. A cannula is inserted entirely through the passageway of the tubular member to extend distally therefrom and straighten the preformed curve of the tubular member for insertion into the trachea. The cannula and tubular member are inserted into the trachea to form an opening to the air passageway of the trachea. Proper placement is detected with formation of air bubbles in the chamber of a syringe connected to the proximal end of the cannula. The cannula is removed from the tubular member allowing the tubular member to assume the preformed curve for preventing injury to the posterior wall of the trachea. The distal nose portions of the speculum are then inserted through the opening into the air passageway of the trachea. The distal nose portions are spread apart in both a longitudinal and a lateral direction to dilate the opening and permit insertion of an ostomy tube into the trachea. With the ostomy tube positioned in the trachea, the speculum is removed from the opening.

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Utica, NY, United States of America

Pasquale Ciaglia