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Percutaneous dilational deviceRelated Patent Categories: Surgery, Instruments, Internal Pressure Applicator (e.g., Dilator)Percutaneous dilational device description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060100657, Percutaneous dilational device. Brief Patent Description - Full Patent Description - Patent Application Claims
Detailed Description of the Invention RELATED APPLICATION INFORMATION [0001] This is a divisional application of U.S. Serial No. 09/729,506, filed December 4, 2000, now Pat. No. 6,637,435. This application claims priority of Provisional Application Serial No. 60/169,368 filed Dec. 7, 1999. TECHNICAL FIELD [0002] This relates to the field of medical devices and more particularly to devices for percutaneous dilation. BACKGROUND OF THE INVENTION [0003] Certain medical devices are known that are used in the atraumatic dilation into a patient, such as percutaneously accessing a patient's air passageway and dilating an opening thereto, and forming an ostomy in the tracheal wall. A tracheal tube is then inserted through the ostomy and into the trachea to establish a passageway for unobstructed air flow. To minimize trauma to the patient, it has been found desirable to initially incise only a small opening as an entrance, and thereafter to enlarge the opening with further dilation. [0004] Sold by Cook Critical Care, Division of Cook Inc., Ellettsville, Ind., is the "Ciaglia Percutaneous Tracheostomy Introducer Set", used for controlled percutaneous introduction of tracheostomy tubes. Sequentially sized dilators (from 12 french to 38 french) are advanced over a wire guide/guiding catheter system to facilitate gradual dilation of the tracheal entrance site to an appropriate size; one such dilator is shown in FIG. 1 and herein below described. The tracheostomy tube is placed by fitting the tube over the appropriate size dilator and advancing the tube into position. Each of the dilators includes an elongated linear shaft for manual gripping and manipulation, and is provided with a curved distal end concluding in a tapered tip that in use is coated with lubricating jelly, all to minimize trauma. First, the smallest dilator (12 french outer diameter) is first selected and placed over a guiding catheter and guide wire that extend through the opening until the tip is adjacent to the opening. Then the tapered tip is urged gently into the percutaneous incision and between adjacent ones of the trachea rings, and is gently withdrawn and reinserted to gradually widen the opening. The first dilator is then withdrawn and removed, and replaced by the next larger sized dilator and the procedure is repeated until the appropriate sized ostomy has been created. [0005] It is desired to simplify the procedure used to create the ostomy and to shorten the length of time involved in its creation. SUMMARY OF THE INVENTION [0006] The present invention is directed toward a single dilator that is used to define the ostomy in one pass, thus replacing the several sequentially sized dilators and eliminating the repeated changing thereof, and thereby greatly simplifying the procedure and substantially shorten the time to define the ostomy, all serving to minimize patient trauma. The single dilator includes a soft, pliant tapered tip identical in shape and size and in tip inner diameter to those of the prior art dilators, and additionally includes a curved distal portion extending from the tapered tip toward the proximal end, and the generally linear shaft. The curved distal portion is tapered to extend from a diameter of 12 french (for example) adjacent the tapered tip, to a diameter of 38 french adjacent the linear shaft. Preferably both the curvature and the taper of the curved tapered distal portion from the distal tip to the shaft is gradual with no discontinuities. Also preferably, the curved tapered distal portion has a gradual transition in flexibility from very flexible at the short distal tip portion to generally rigid at the generally linear shaft portion, such as by gradually changing its wall thickness. [0007] The resultant shape of the dilator of the present invention can be said to resemble the horn of a rhinoceros. Particularly useful for tracheostomies, the continuing curve of the distal end portion enables the increasingly longer inserted portion of the dilator to be situated in the trachea thus facilitating clearing the posterior tracheal wall. [0008] Preferably the curved tapered distal portion and the short distal tip portion are provided with a hydrophilic coating that obviates the need for lubricating jelly and provides a very low coefficient of friction when hydrated, thus facilitating insertion into and withdrawal from the tracheal opening. [0009] An embodiment of the invention will now be described by way of example with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is an elevation view of a Prior Art dilator; [0011] FIGS. 2 and 3 are elevational and longitudinal section views of the dilator of the present invention; and [0012] FIG. 4 is an elevation view of the dilator in position over a guide wire and extending through an entrance to a trachea. DETAILED DESCRIPTION [0013] Dilator 100 of FIG. 1 is a Prior Art dilator, namely, one of a series of dilators found in the "Ciaglia Percutaneous Tracheostomy Introducer Set" sold by Cook Critical Care, Division of Cook Inc., Ellettsville, Ind., used for controlled percutaneous introduction of tracheostomy tubes and having sequentially sized dilators (from 12 french to 38 french). Dilator 100 in particular is the largest of the series used last in the sequence to attain a tracheal entrance of about 38 french. Dilator 100 includes a shaft portion 112 extending from a proximal end 114, a tip portion 118 adjacent to distal end 120, and a curved intermediate section 130 extending between shaft portion 112 and tip portion 118. An insertion depth marking 122 is defined a distance of about 50 mm (2.0 in) from distal end 120, and on dilator 100 is positioned midway along curved intermediate section 130. A central passageway 124 extends from proximal end 114 to distal end 120. [0014] Tip portion 118 on Prior Art dilator 100 is about 20.0 mm (0.79 in) in length and has a taper along each side of about 0.223 mm per mm (0.223 in per in), or about 12.6 degrees. (On smaller dilators of the "Introducer Set" the length of tip portion 118 is shorter while the taper remains the same; the insertion depth marking 122 may be along the linear shaft portion 112 on the smaller dilators.) Curvature of the centerline of curved intermediate section 130 is a radius R of about 80 mm (3.15 in) over an angular distance .theta. of about 20.degree. to 40.degree.. Wall thickness immediately at the distal end 120 is about 0.406 mm (0.016 in), and thickens over the portion extending for 5.99 mm (0.236 in.) from distal end 120 to a thickness of about 1.09 mm (0.043 in), which is the wall thickness of curved intermediate section 130 and the shaft portion 112, and at proximal end 114. [0015] In Prior Art dilator 100, the outer diameter from the location from tip portion 118 is constant to proximal end 114 and is 38 french or 12.7 mm (0.491 in). Also, the wall thickness between tip portion 118 and proximal end 114 is constant at 1.09 mm (0.043 in). The durometer is measured at about 55 to 60 Shore D hardness. [0016] Dilator 10 of the present invention is shown in FIGS. 2 to 4 and includes a shaft portion 12 extending from a proximal end 14, and a curved tapered distal portion 16 extending from shaft portion 12 to a small tip portion 18 at distal end 20. Demarcation 22 denotes the location at which the outer diameter is 38 french. A central passageway 24 extends completely there through from proximal end 14 to distal end 20. A marking 26 is identified toward proximal end 14 from demarcation 22 that indicates the recommended depth of maximum insertion into the skin, and that is at that location at which the shaft portion 12 and the curved tapered distal portion 16 meet. [0017] Preferred dimensions of dilator 10 for use especially in tracheostomy procedures are: an overall length of about 196 to 210 mm (7.75 to 8.25 in); a length of about 110 mm (4.33 in) from distal end 18 to insertion depth marking 26; an inner diameter at distal end 20 of about 2.79 mm (0.110 in) and that extends the short length of flexible tip portion 18, about 3.18 mm (0.125 in); an outer diameter at distal end 18 of about 12 french or 4 mm (0.140 in); and an outer diameter at proximal end 14 of about 50 french or 16.5 mm (0.650 in), with an inner diameter of about 12.0 mm (0.473 in). The outer diameter at demarcation 22, as mentioned above, is about 38 french or 12.7 mm (0.491 in) and is located at about a distance of 80 mm (3.150 in) from distal end 20; and the inner diameter at demarcation 22 is about 7.72 mm (0.304 in). Continue reading about Percutaneous dilational device... 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