IMPROVED BILIARY CATHETER

Abstract: An improved biliary catheter (10) is disclosed. The catheter (10) comprises a tube (12) constructed from a polyurethane or nylon having a durometer of about 60 D and coated with a hydrophilic coating to provide lubricity, kink resistance and suppleness. The tube (12) has substantially cylindrical sidewalls and a proximal end (12a) for connection to a source of contrast medium (18) and a distal end (12b) for entry into the common biliary duct of a patient. The tube contains a first crescent-shaped lumen channel (34) extending between the proximal and the distal end, the first lumen channel transporting the contrast medium (18) from the source of contrast medium (18) to the biliary duct; and a second circular lumen channel (32) extending between the proximal end and said distal end for facilitating the insertion and threading of a spring wire guide (24) into the dual-lumen biliary catheter.

Description: IMPROVED BILIARY CATHETER Claim of Priority This application is a continuation-in-part of U.S. Serial No. 07/880,842 entitled Improved Biliary Catheter file May 11, 1992. Field of the Invention The present invention is directed to the field o Endoscopic Retrograde Cholangiopancreatography (ERCP) catheters. In particular, the present invention is directed to an ERC catheter which can more easily accommodate spring wire guid insertion and threading as well as contrast media infusion. Background of the Invention Endoscopic Retrograde Cholangiopancreatograph (ERCP) is an endoscopic technique which involves the placemen of a sideviewing instrument within the descending duodenum The procedure eliminates the need for invasive surgica procedures for identifying biliary stones and other obstruction of the biliary and pancreatic ducts. Utilizing this technique, the Papilla of Vater an common biliary duct are cannulated, contrast media injected, an pancreatic ducts and the hepatobiliary tree visualized radiographically or examined with a duodeno-fiberscope. Skilled medical practitioners can visualize approximately 90 to 95 percent of the biliary and pancreatic ducts using this technique. ERCP is typically performed on an x-ray table. During the procedure, the patient's oropharynx is anesthetized with topical lidocaine, and the patient is sedated intravenously with diazepam. Atropine and glucagon are given intravenously to induce duodenal hypotonia. The ERCP procedure has heretofore typically been performed by the endoscopic introduction of a single lumen catheter into the pancreatic and common biliary ducts of a patient. Such ERCP catheters have typically been constructed from teflon. At times, a spring wire guide may be placed in the lumen of the catheter to assist in cannulation of the ducts. A stylet, used to stiffen the catheter, must first be removed prior to spring wire guide insertion. The introduction of the spring wire guide eliminates the ability to inject contrast media, or makes it highly cumbersome. To summarize the procedure, an EPCP catheter is initially inserted through the endoscope and into the biliary or pancreatic ducts. If diffficulty is encountered or if the operator so desires, a spring wire guide is threaded into the catheter to assist in the cannulation. After the catheter is inserted into the duct and threaded over the spring wire guide, the spring wire guide is removed. A radio-opaque contrast medium is then injected through the single lumen of the catheter in order to identify obstructions such as bile stones. Onc located and identified, such stones can then be eliminated o destroyed by methods such as mechanical lithotripsy, utilizin a device such as Olympus BML-10/20 Mechanical Lithotriptor. This method of performing ERCP has severa disadvantages. Most notably, it relies upon the use of a singl lumen catheter which is threaded over the spring wire guide o pushed by a stylet and then, upon the removal of the style spring wire guide, used for infusing radio-opaque contrast medi or dye into the biliary and pancreatic ducts. Unfortunately the process of withdrawing the stylet spring wire guide in orde to clear the single lumen for contrast media or dye infusion frequently repositions the catheter. Thus, when the radio opaque or contrast media is injected into the catheter, th catheter is often improperly positioned for proper fluoroscop or x-ray visualization. Moreover, this method presents th further problem of having to repeatedly remove the stylet or a approximate six foot long spring wire guide, maintain it cleanliness and then reinsert it into the catheter. Finally single lumen catheters frequently experience the problem o back-flow in which the radio-opaque dye is squirted back out th catheter and onto the administering medical professional. The above problems often result in the need to repea the procedure, and can lead to a time consuming exercise o trial and error. Multiple attempts at properly positioning th catheter and spring wire guide are often necessary. Because th ERCP procedure is performed under sedation, the additional tim required for proper catheter positioning tends to increase th risk to the patient. Furthermore, because of the considerable expense of maintaining a procedure room, the use of single lumen ERCP catheters can add considerably to the expense of the procedure. Accordingly, ERCP procedures have heretofore been performed by only the most skilled endoscopists. It would be desirable to provide a dual or multi-lumen ERCP catheter in which one lumen could be utilized to accommodate the spring wire guide or diagnostic or therapeutic device, and in which a second lumen could be utilized for contrast media or dye infusion. As noted above, most prior art biliary catheters have been constructed from teflon. While teflon possesses a low coefficient of friction and can be extruded into a catheter having a long passageway, teflon is an unsuitable material from which to construct a multiple lumen catheter for ERCP applications. Because it cannot be extruded properly, attempts at manufacturing a multiple lumen catheter from teflon have resulted in catheters having too narrow a wall thickness. Furthermore, while other polymers such as polyurethane and polyamide can be extruded to form a dual-lumen catheter for ERCP, most polyurethanes are too soft for ERCP applications and will kink, bunch up or buckle in use. After such kinking occurs, the catheter is rendered inoperative for injecting contrast media or dye. In view of the above problems, it would be desirable to provide a multi-lumen ERCP catheter in which one lumen may be utilized to inject a contrast media or dye and the second lumen may be utilized for spring wire guide insertion and threading or inserting other devices. It would also be desirable to provid a catheter having calibrated or digitized bands to determin precise points of insertion of the catheter. Such a cathete would facilitate both spring wire guide feeding and adjustmen as well as the infusion of contrast media without the need t remove the spring wire guide. Such a catheter would be mor hygienic and would further widen the pool of medica professionals who could perform ERCP procedures, and woul reduce the time necessary to complete ERCP, thereby reducing th risks to the patient undergoing the procedure. Such a cathete would allow smooth manipulation of the guide wire an simultaneous contrast medium injection. This will result i safer more effective ERCP. Such a catheter may allo cannulation of the right and left hepatic ducts and cysti ducts. Such a catheter would also allow laser lithotripty i the bile duct while the simultaneous injection of contras medium is taking place. Summary of the Invention In view of the above long-felt need, an improve biliary catheter is contemplated by the present invention. Th catheter of the present invention permits the cannulation an radiological examination of the biliary and pancreatic ducts o a patient during ERCP procedures. In a simplest embodiment, th present invention is directed to a biliary catheter comprisin a cannula having a proximal end for connection to a source o radio-opaque contrast media to be infused through the cannul and into a common biliary duct of a patient, and a distal en for entry into common biliary duct of a patient such that sai radio-opaque contrast media can be infused therethrough. The cannula comprises first lumen means for the introduction and threading of a spring wire guide through the catheter so as to promote insertion of the distal end into the biliary duct, and second lumen means for infusing and transporting said contrast media between said proximal and distal ends. In a further embodiment, the catheter is constructed from a material having a durometer of about 60D. A key feature of the present invention is the treatment of the catheter with a hydrophilic coating. The hydrophilic coating of the present invention provides a highly lubricated surface which is activated by the biliary fluids of the patient. The hydrophilic coating further functions to soften the material so as to increase the suppleness and kink resistance and lubricity of the catheter, and to reduce its durometer. This coating is applied to the outer surface of the catheter, and may optionally also be applied within the spring wire guide lumen. In a yet a further embodiment, the catheter comprises a tube having substantially cylindrical sidewalls and having a proximal end for connection to a source of a radiopaque contrast media and for the introduction of a spring wire guide and a distal end for entry into a biliary duct, said tube containing a first crescent-shaped lumen channel extending between said proximal end and said distal end, said first lumen channel transporting a radiopaque contrast medium from said proximal end to said distal end; and a second circular lumen channel extending between said proximal end and said distal end for facilitating the insertion and threading of a spring wire guide into said dual-lumen biliary catheter. In still yet a further embodiment, the invention i directed to a biliary catheter comprising a tube constructe from a polyurethane or nylon having a durometer of about 60D an coated with a hydrophilic coating to provide kink resistance an suppleness to the polyurethane or nylon, said tube havin substantially cylindrical sidewalls and having a proximal en for connection to a source of contrast media and a distal en for entry into a biliary duct; said tube containing a firs crescent-shaped lumen channel extending coaxially between sai proximal and said distal end, said first crescent-shaped lume channel transporting said contrast medium from said source o contrast medium to said biliary duct; and a second circula lumen channel extending between said proximal end and sai distal end for facilitating the insertion and threading of spring wire guide into said dual-lumen biliary catheter. The present invention further includes means fo locking the position of the guide wire. In addition, th present invention includes a calibrated tip which may b recessed. The present invention can be used for numerous ERC applications and is particularly suited for simultaneo guidewire manipulation or stent placement with ongoing injectio of contrast media. These and other features and advantages o the present invention will become clear from the followi detailed description. Brief Description of the Figures Figure 1 is a perspective view of the dual-lum biliary catheter of the present invention. Figure 2 is a partially broken away section view of the dual-lumen biliary catheter of the present invention. Figure 3 is a perspective view of the dual-lumen biliary catheter of the present invention which highlights the contrast stripes at the distal end of the catheter. Figure 3A is a section view highlighting the dual lumens of the biliary catheter of the present invention along line 3A-3A. Figure 4 is a section view of the branching connector which joins the spring wire guide infusion line and contrast medium infusion line of the present invention. Figure 5 is a perspective view of the contrast medium infusion line of the present invention. Figure 5A is a section view of the contrast medium infusion line of Figure 5. Figure 6 illustrates the introduction of the catheter of the present invention into a common biliary duct. Figure 7 illustrates the use of the dual-lumen catheter of the present invention with a fiberscope. Figure 8 is a section view of an alternative distal tip configuration for the biliary catheter of the present invention. Figure 8A is a further alternative embodiment tip configuration which illustrates the calibrated tip. Figure 9 is a section view of tubing clamp which may be utilized in the present invention to lock the relative positions of the catheter and spring wire guide which may be utilized with the present invention. Figure 9A is a section view of an alternative tubin clamp. Figure 10 is a side perspective view of spring wir guide feed apparatus which may be utilized with the presen invention. Figure 10A is a side perspective view of a alternative spring wire guide feed arrangement including a sna lock adapter which may be utilized with the present invention Figures 11A and 11B are side views of a catheter of a alternative embodiment having a tapered tip and digitize markings. Figure 12 is a section view of the catheter of Figur 11A along line 12-12. Figures 13A and 13B illustrate the alternative fee mechanism of Figure 10A including guide wire locking mechanism Detailed Description of the Preferred Embodiment The improved biliary catheter of the present invention is described with reference to the enclosed Figures wherein the same numbers are utilized where applicable. For the purposes of description, the present invention will be described in the context of its use in the cannulation and visualizing of the common biliary duct of a patient pursuant to an ERCP procedure. It is to be recognized that the present invention is applicable to all ERCP procedures involving the cannulation and radiological visualization of the common biliary, pancreatic, common hepatic and cystic ducts. Referring to Figures 1 to 5A, a biliary catheter 10 in accordance with the present invention is illustrated. Referring to Figure 1, in a preferred embodiment, the catheter of the present invention comprises a cannula or tube 12 having a proximal end 12a for connection to a source of contrast media and a distal end 12b for insertion into the biliary duct of a patient. Tube 12 has a substantially circular cross-sectional shape. Tube 12, in a preferred embodiment, has a length of approximately 200 centimeters. This length permits the catheter 10 to be inserted endotracheally into a patient via an endoscope and reach biliary and pancreatic ducts located adjacent the patient's duodenum via an attached fiberscope during an ERCP procedure. The proximal end 12a of tube 12 attaches to branching means 14 which couples the tube 12 to spring wire guide feeding means 16 and contrast medium infusion means 18. In a preferred embodiment as shown in Figures 1, 2 and 4, branching means 14 comprises a wedge-shaped polymeric branching connector 15 which joins the spring wire guide feeding means 16 and contrast mediu infusion means 18. The branching connector 15 may include connector 19 having an affixed apertured wing 20. Referring to Figures 1 and 4, the spring wire guid feeding means 16 in a preferred embodiment comprises an eightee gauge luer lock hub 17 which couples to the branching means 1 via a dovetail socket 17a. The spring wire guide feeding mean 16 is utilized to feed a spring wire guide 24 into and out o the catheter 10. The spring wire guide utilized in a preferre embodiment should have a diameter of .035 inches. The use of spring wire guide having this diameter permits the spring wir guide to be used for placing an indwelling stent, to b discussed below. The spring wire guide 24 may optionally be coated wit teflon in order to add to its lubricity. The spring wire guid of the present invention may further be fed and withdrawn wit the assistance of an auxiliary apparatus such the spring wir guide feed apparatus disclosed in U. S. Serial No. 07/608,23 entitled "Hand Held Device For Feeding A Spring Wire Guide" filed November 2, 1990, and now U.S. Patent No. 5,125,90 assigned to Arrow International Investment Corp., assignee o the present invention, and which is incorporated herein b reference as if set forth in full. A perspective view of suc a device 27 is illustrated in Figure 10. In an alternativ embodiment shown in Figures 10A, 11A and 11B the wire guide fee device 27 is affixed to snap lock adapter 29 for locking th position of the wire. Figures 13A and 13B illustrate th respective unlocked and locked positions of the adapter. Referring to Figures 1, 2, 5 and 5A, the contrast medium infusion means 18 in a preferred embodiment preferably comprises a polymeric tube 26 which couples to a twenty-gauge connector 28. The connector 28 has a threaded outer surface 30 onto which may be affixed a cap or stopper (not shown) . As shown in Figure 5A, the interior 28a of the connector 28 is luer shaped and is designed to be coupled to a syringe containing radio-opaque contrast media or dye. The contrast media or dye is injected down tube 26 and into a contrast media lumen 34 to be discussed below. Referring to Figures 2 and 3, the distal end 12b of the tube 12 is shown in detail. The distal end of the catheter 12b includes means 25 for contrasting the outer distal surface of catheter radio-opaque. Contrast means 25 facilitates the visual identification of the distal end of catheter 10 by the endoscope. In a preferred embodiment, means 25 comprises a plurality of non-toxic ink stripes 25 such as sold under the specification LON-1342 by Colorcon, Inc. of West Point, Pennsylvania. It is to be appreciated that contrast stripes 25 comprising other materials may be utilized in the biliary catheter of the present invention. Moreover, it is to be appreciated by those skilled in the art that the entire catheter 10 or portions thereof may be or applied with any acceptable contrast medium. As shown in Figures 11A and 11B, the tip 12b of the catheter may be calibrated 25a at predetermined intervals such as five millimeters. In this embodiment catheter tip 12b is tapered to facilitate ease of insertion of the guide wire. It is also to be appreciated that the catheter tip may be curved to facilitate entry of the guide wire. Referring to Figures 3 and 3A, the lumens 32, 34 o catheter 10 of the present invention are shown so as to detai their cross-sectional shape. In a preferred embodiment, th catheter 10 includes a spring wire guide lumen means 32 an contrast media lumen means 34. In a preferred embodiment, th lumen means 32, 34 extend coaxially within the tube 12 along it entire length between the proximal end 12a and distal end 12b Referring to Figures 8, 11, IIA and 12 alternative distal en 12b is shown tapered with the contrast media lumen means 3 terminating proximal of the spring wire guide lumen means 32. Spring wire guide lumen means 32 is circular in cross section. The top of spring wire guide lumen 32 is defined by a arcuate septum 32a which defines the interior sidewall of th contrast medium lumen 34. In a preferred embodiment, contras medium lumen 34 is crescent-shaped. While the present inventio is described in the context of a biliary catheter having dua lumens, it is to be appreciated by those skilled in the art tha the present invention embodies catheters having more than tw lumens. Further, while the present invention is described wit respect to a contract media lumen 34 having a crescent shape, i is to be appreciated that the present invention also embodie catheters in which the contrast media lumen may assume one of plurality of geometric shapes. The catheter 10 of the present invention is preferabl constructed from a polyurethane or nylon having a durometer o about 60D or greater. One polyurethane known to be suitable i the present invention is a polyether-polyurethane calle TECOFLEX sold under part number EG-60D-B20 by Thermedics. This material has a hardness of 60D, a yield elongation percentage of 275 to 475 and a yield tensile strength in pounds per square inch of 5,000. In a more preferred embodiment, the resin of the present invention comprises a mixture of 20% barium sulfate, 60% Nylon 11 BESVOA and 20% PeBax (12055A00) . Nylon II BESVOA and Pebax are manufactured by Atochem. A further important feature of the present invention is the addition of a hydrophilic coating on the outer surface of the catheter 10 and optionally within the spring wire guide lumen 32. The hydrophilic coating when applied to the catheter, imparts suppleness and kink resistance to the catheter. The hydrophilic coating further reduces the durometer of the polyurethane or nylon. The hydrophilic coating of the preferred embodiment comprises the following components: (a) 150 milliliters of Methylene Chloride (MeCl) ; (b) 50 milliliters Gensolv D DuPont Freon Solvent: (c) 2.25 milliliters Tyrite 7617 Adhesive, and (d) 2.13 grams of Polyethylene Oxide (PEO) . The hydrophilic coating of the preferred embodiment is applied to the catheter pursuant to the following process. Initially, 150 milliliters of MeCl is poured into a beaker. Next, 50 milliliters of Gensolv D is added, and the beaker is placed on stirrer plate. A stirring magnet is then dropped into the beaker and the stirring plate is activated. Stirring is adjusted until a vortex forms. Next, 2.13 grams of PEO are slowly added to the stirring solution. The solution is stirred continuous for 10 minutes, in order to break up any lumps of PEO. Using a syringe, Tyrite 7617 adhesive is added to the stirring solution, which is permitted to stir for an additiona five minutes. The stirred solution is then poured into a 20 milliliter graduated cylinder. The catheter 10, with its end sealed off, is the dipped into the cylinder until it reaches the bottom of th cylinder. The catheter 10 is left in the cylinder for 2- seconds, quickly retrieved and the excess solution shaken off The catheter is then air-dried for a minimum 24 hours. As a optional step, after the catheter is air-dried for 24 hours solution may be injected down the spring wire guide lumen 32 o the catheter. Air is blown through the lumen immediately t drive out excess solution. Air is blown through the cathete for three to five minutes, and the catheter is left to dry fo a minimum of 24 hours. The catheter 10 with hydrophilic coating provides highly lubricated surface which is activated by the biliar fluids of the patient. The hydrophilic coating may also b activated by the gastric fluids which enter the endoscope. Th hydrophilic coating reduces the durometer of the catheter, an imparts kink resistance and suppleness to the catheter. While the present invention is being described in th context of a preferred hydrophilic coating, it is to b appreciated that other hydrophilic coatings may be utilized i the present invention. Examples of such hydrophilic coating are found and described in U. S. Patent No. 4,943,460 entitle "Process for Coating Polymer Surfaces and Coated Product Produced Using Such Process." Another hydrophilic coating i Hydromer ® "Slippery When Wet" coating manufactured by Hydromer Inc. The operation and use of the biliary catheter 10 of the present invention is now described with reference to the Figures. Initially, the patient is sedated, or in rare situations, placed under general anesthesia. The spring wire guide 24 is inserted through an endoscope and exits through the side of an attached fiberscope 36 as shown in Figure 7 situated in the patient's duodenum 38. The catheter 10 is then threaded over the spring wire guide 24 via spring wire guide lumen 32 and fed through the fiberscope 36 and into the common bile duct 40. Next, a pre-filled syringe of radio-opaque dye or contrast media is attached to twenty-gauge luer shaped connector 28. A sufficient amount of dye to fill the catheter is then injected into tube 26. The catheter 10 is inserted through the accessory channel of the endoscope and threaded over the spring wire guide 24 via lumen 32. The catheter 10 exits the side of the fiberscope and enters the common bile duct, as shown in Figures 6 and 7. Referring to Figure 9, clamp 37 may be used to lock the relative positions of the catheter and spring wire guide. An example of clamps which achieves this function are the Series 340 clamps by Halkey Medical of St. Petersburg, FLA. Contrast media is then injected into the contrast medium lumen 34 which exits at distal end 12b and into the common biliary duct 40 thereby permitting x-ray or fluoroscopic visualization of the duct 40. Digitized markings 25a facilitate precise adjustment of the catheter. If the position of the catheter needs to be adjusted, the spring wire guide 24 is advanced and the catheter 10 advanced accordingly. The catheter can be rapidly adjusted and contrast media and dye can be repeat infused without the need for repeated insertion and removal the spring wire guide 24. The present invention thus provides for the probi with the spring wire guide 24, the injection of dye or contra media, via contrast media lumen 34, further probing, a further injection of dye until a proper catheter position achieved. The present invention eliminates the time consumi step of removing the spring wire guide 24 prior to each chan in catheter position and contrast medium infusion. The use the catheter of the present invention can save over twen minutes of time during a typical ERCP procedure. In additio a laser fiber for biliary lithotripty can be placed through o lumen with ongoing injection of contrast medium or fluid in t second lumen. Further, selective cannulation of the right a left hepatic ducts, cystic ducts, or pancreas becomes mo directed, safe and efficient. A particular feature of the present invention is i adaptability for use in placing a stent around a bilia calculus 42 or cystic or pancreatic obstruction. approximately five percent of all ERCP cannulations, surgery mandated. However, surgery is often not always possible at t time of the ERCP procedure. In such situations, a stent typically placed within the common biliary or pancreatic du around the calculus. As used in such an application, the catheter 10 is utiliz in association with a spring wire guide 24 having a leng greater than twice the length of the catheter 10, or over 4 centimeters in length. The spring wire guide would be threaded with the catheter into endoscope as described above. The spring wire guide should preferably have a diameter of .036 inches. The catheter 10 of the present invention is then threaded over the spring wire guide as discussed above, and fed into the common biliary duct. Contrast media or dye is infused, and the calculus 42 is located as shown in Figure 6. The catheter 10 is then removed from the endoscope. Because the spring wire 24 guide has a length greater than twice that of the catheter 10, the catheter 10 can be completely removed from the endoscope over the spring wire guide 24 without the need for removing the spring wire guide from the endoscope. After the catheter 10 is removed, a stent may be placed forward of a guiding catheter and is threaded over the spring wire guide. The guiding catheter is utilized to push the stent into the endoscope, over the spring wire guide, into the common biliary duct and around the biliary calculus 42. With the stent in place, the spring wire guide 24 is then removed along with the guiding catheter. It is to be appreciated by those skilled in the art that other accessories such as stone baskets, three pronged retrievers and fiber optic cameras can be used interchangeably in the first lumen with the guide wire. The present invention has been described with reference to the attached Figures and described embodiments. It is to be appreciated that other embodiments may fulfill the spirit and scope of the present invention and that the true nature and scope of the present invention is to be determined with reference to the claims appended hereto.

Claims: What is claimed is: 1. A biliary catheter comprising: a cannula having a proximal end for connection to source of radio-opaque contrast media to be infused through th cannula and into a common biliary duct of a patient, and distal end for entry into common biliary duct of a patient suc that said radio-opaque contrast media can be infuse therethrough, said cannula comprising first lumen means for th introduction and threading of a spring wire guide through th catheter so as to promote insertion of the distal end into th biliary duct, and second lumen means for infusing and transporting sai contrast media between said proximal and distal ends. 2. The biliary catheter of claim 1 furthe comprising means on the distal end of said catheter fo rendering said distal end visible by an endoscope. 3. The biliary catheter of claim 2 wherein sai means comprises a plurality of stripes affixed to the oute surface of said distal end of said catheter. 4. The biliary catheter of claim 3 wherein sai stripes comprise digitized markings. 5. The biliary catheter of claim 1 wherein sai catheter has a length of approximately 200 centimeters. 6. The biliary catheter of claim 1 wherein said catheter is constructed from polyurethane. 7. The biliary catheter of claim 1 wherein said catheter is constructed from a material comprising nylon, pebax and barium sulfate. 8. The biliary catheter of claim 1 wherein said distal end is tapered. 9. The catheter of claim 1 wherein said spring wire guide has a length at least two times that of the catheter. 10. The catheter of claim 6 wherein said polyurethane has a durometer of at least about 60D. 11. The dual lumen biliary catheter of claim 6 wherein said polyurethane is treated with a hydrophilic coating, said coating being activatable in the presence of biliary fluid and providing lubricity on the outer surface of said catheter and increasing the suppleness and kink resistance of said catheter. 12. A biliary catheter comprising: a tube having substantially cylindrical sidewall and having a proximal end for connection to a source of contras medium and a distal end for entry into a biliary duct of patient; said tube containing a first lumen channe extending between said proximal end and said distal end, sai first lumen channel adapted to transport said contrast mediu from said source of contrast medium to said biliary duct; and a second lumen channel extending between sai proximal end and said distal end for facilitating the insertio and threading of said biliary catheter over said spring wir guide. 13. The dual lumen biliary catheter of claim 1 wherein said polyurethane is treated with a hydrophilic coatin which provide lubricity on the outer surface of said cathete and increases the suppleness and kink resistance of sai catheter. 14. A dual-lumen biliary catheter comprising: a tube having substantially cylindrica sidewalls, said tube having a proximal end and a distal end fo entry into the common biliary duct of a patient, said tub containing a first crescent-shaped lumen channel extendin between said proximal end and said distal end, said first lume channel transporting a radiopaque contrast medium from sai proximal end to said distal end; and a second circular lumen channel extending between said proximal end and said distal end for facilitating the insertion and threading of a spring wire guide into said biliary catheter. 15. A biliary catheter comprising: a tube constructed from a polyurethane having a durometer of about 60D and coated with a hydrophilic coating activatable upon exposure to biliary fluid to provide kink resistance, lubricity and suppleness, said tube having substantially cylindrical sidewalls and having a proximal end for connection to a source of contrast medium and a distal end for entry into a biliary duct; said tube containing a first crescent-shaped lumen extending between said proximal and said distal end, said first lumen channel transporting said contrast medium from sai source of contrast medium to said biliary duct; and a second circular lumen channel extending between said proximal end and said distal end for facilitating th insertion and threading of a spring wire guide into said dual lumen biliary catheter. 16. The biliary catheter of claim 15 wherein sai second circular lumen channel is coated with said hydrophili coating. 17. A method for placing a catheter and radio-opaqu medium into a biliary duct comprising the following steps: inserting a spring wire through an endoscope and int a biliary duct; threading a biliary catheter over said spring wir guide and into said biliary duct; and infusing a radio-opaque medium through said biliar catheter and into said biliary duct such that said biliary duc may be visualized radiologically. 18. The method of claim 17 wherein said spring wir guide has a length greater than twice that of said biliar catheter. 19. A method for placing a biliary stent around biliary calculus comprising the following steps: inserting a spring wire through an endoscope and int a biliary duct containing a biliary calculus; threading a biliary catheter over said spring wir guide and into said biliary duct containing said biliar calculus, said spring wire guide having a length greater tha twice that of said biliary catheter; infusing a radio-opaque medium through said biliar catheter and into said biliary duct proximate to said biliar calculus such that said biliary calculus may be visualize radiologically; removing said biliary catheter from said endoscope an unthreading said biliary catheter from said spring wire guid such that the length of said spring wire guide permits sai biliary catheter to be completely unthreaded from said spring wire guide while maintaining the position of said spring wire guide in said biliary duct; and threading a biliary stent over said spring wire guide and into biliary duct using a guiding catheter such that said stent is placed around said visualized biliary calculus. 20. A method for placing a stent around a pancreatic obstruction comprising the following steps: inserting a spring wire through an endoscope and into a pancreatic duct containing a pancreatic obstruction; threading a catheter over said spring wire guide and into said pancreatic duct containing said obstruction, said spring wire guide having a length greater than twice that of said catheter; infusing a radio-opaque medium through said catheter and into said pancreatic duct proximate to said obstruction such that said obstruction may be visualized radiologically; removing said catheter from said endoscope and unthreading said catheter from said spring wire guide such that the length of said spring wire guide permits said catheter to be completely unthreaded from said spring wire guide while maintaining the position of said spring wire guide in said pancreatic duct; and threading a stent over said spring wire guide and into said pancreatic duct using a guiding catheter such that said stent is placed around said visualized obstruction. 21. A method for placing a stent around a cystic obstruction comprising the following steps: inserting a spring wire through an endoscope and int a cystic duct containing a cystic obstruction; threading a catheter over said spring wire guide an into said cystic duct containing said obstruction, said sprin wire guide having a length greater than twice that of sai catheter; infusing a radio-opaque medium through said cathete and into said cystic duct proximate to said obstruction suc that said obstruction may be visualized radiologically; removing said catheter from said endoscope an unthreading said catheter from said spring wire guide such tha the length of said spring wire guide permits said catheter to b completely unthreaded from said spring wire guide whil maintaining the position of said spring wire guide in sai cystic duct; and threading a stent over said spring wire guide and int said cystic duct using a guiding catheter such that said sten is placed around said visualized obstruction.

Inventors: JACOB HAROLD, LEIGHTON DAVID F, WEAVER GEORGE W, JACOB, HAROLD, LEIGHTON, DAVID, F., WEAVER, GEORGE, W.
Applicants: ARROW PRECISION PROD INC, JACOB HAROLD, LEIGHTON DAVID F, WEAVER GEORGE W, ARROW PRECISION PRODUCTS, INC.
Application year: 1993
Main classification: A61M25
IPC codes: A61B17, A61F2, A61M25