Multi-lumen endoscopic catheter

• US 5,599,299 A
• Filed: 01/31/1994
• Issued: 02/04/1997
• Est. Priority Date: 05/11/1992
• Status: Expired due to Term

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation), Medical Instruments Development Incorporated
• Original Assignee: Arrow Precision Products, Inc.
• Inventors: Jacob, Harold, Leighton, David F., Weaver, George W., Holsinger, Damond C.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/189,317
• Time in Patent Office: 1,100 Days
• Field of Search: 604/49, 604/52-53, 604/280, 604/96, 604/102, 604/54, 606/108, 606/167, 606/45, 606/46
• US Class Current: 604/540
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Abstract

Multi-lumen catheters are intended for advancement through the accessory channel on endoscope into a body passage into the gastrointestinal system. The catheters have two or more independent lumens extending continuously to ports at the distal tip for injection of a contrast medium simultaneously with a guide wire for ERCP procedures and for passage of accessories such as visualization devices, polypectomy snares, cytology brushes, papillotomes and stone baskets for catheterization, diagnosis and treatment within the biliary tract. Use of balloons for maintaining a catheter in fixed position in the biliary tract and for dilatation is also disclosed. The catheters employed are extrusions of a resin comprised of nylon and PEBA. The catheters may also be extruded from polyurethane. Multi-lumen catheters having a reduced diameter distal tip portion on which a dilatation balloon is located are also disclosed. The reduced diameter distal tip portion may serve as a platform for support of a stent.

Claims

1. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

threading said catheter and said wire guide through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide in said first lumen of said catheter; and

advancing an instrument through a third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said wire guide in said first lumen of said catheter.

2. The method of claim 1, further comprising the additional steps of:

further advancing said wire guide through said distal end of said catheter and along said duct;

further advancing said catheter along said wire guide and along said duct to a second desired position in said duct;

infusing said contrast medium through said second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide in said first lumen; and

advancing said instrument through said third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said wire guide in said first lumen of said catheter.

3. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a stiffening element threaded therethrough, comprising the steps of:

threading said catheter and said stiffening element through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said stiffening element in said first lumen of said catheter; and

advancing an instrument through a third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said stiffening element in said first lumen of said catheter.

4. A method of dilating a duct of a patient using a catheter having at least three lumens, two of said lumens having a distal opening at a distal end of said catheter, and a third lumen communicating with a balloon disposed proximal to said distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

threading said catheter and said wire guide through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide in said first lumen of said catheter; and

inflating said balloon to dilate said duct by infusing a fluid through a third lumen of said catheter while maintaining said wire guide in said first lumen of said catheter.

5. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

threading said catheter and said wire guide through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide in said first lumen of said catheter; and

advancing an instrument through a third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said wire guide in said first lumen of said catheter, wherein said instrument comprises at least one of a stone extractor, a papillotome, forceps, a biopsy cutter, a cytology brush, a snare and a basket.

6. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough and a second lumen of said catheter having an instrument threaded therethrough, comprising the steps of:

threading said catheter and said wire guide and instrument through an endoscope and into said duct to a desired position;

infusing a contrast medium through a third lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide and instrument in said first and second lumens of said catheter; and

advancing said instrument through the distal opening of said second lumen of said catheter while maintaining said wire guide in said first lumen of said catheter, wherein said instrument comprises at least one of a stone extractor, a papillotome, forceps, a biopsy cutter, a cytology brush, a snare and a basket.

7. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

threading said catheter and said wire guide through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide substantially within said first lumen of said catheter such that said duct may be visualized through the use of said contrast medium without requiring the removal of said wire guide from said duct or said first lumen; and

advancing an instrument through a third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said wire guide substantially within said first lumen of said catheter.

8. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a stiffening element threaded therethrough, comprising the steps of:

threading said catheter and said stiffening element through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said stiffening element substantially within said first lumen of said catheter such that said duct may be visualized through the use of said contrast medium without requiring the removal of said stiffening element from said duct or said first lumen; and

advancing an instrument through a third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said stiffening element substantially within said first lumen of said catheter.

9. A method of dilating a duct of a patient using a catheter having at least three lumens, two of said lumens having a distal opening at a distal end of said catheter, and a third lumen communicating with a balloon disposed proximal to said distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

threading said catheter and said wire guide through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide substantially within said first lumen of said catheter such that said duct may be visualized through the use of said contrast medium without requiring the removal of said wire guide from said duct or said first lumen; and

inflating said balloon to dilate said duct by infusing a fluid through a third lumen of said catheter while maintaining said wire guide substantially within said first lumen of said catheter.

10. A method of study of a biliary tract using a catheter having at least three lumens, comprising the steps of:

threading a wire guide through a first lumen of said catheter;

inserting said catheter and said wire guide through an endoscope to a first position within said biliary tract;

infusing a contrast medium through a second lumen of said catheter for visualizing said biliary tract at said first position while maintaining said wire guide within said first lumen of said catheter;

repositioning said catheter and said wire guide at least at a second position within said biliary tract and infusing said contrast medium while maintaining said wire guide within said first lumen; and

advancing a papillotome through a third lumen of said catheter and incising tissue at least at one of said first position and said second position within said biliary tract with said papillotome while maintaining said wire guide within said first lumen of said catheter.

11. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

threading said catheter and said wire guide through an endoscope and into said duct to a desired position;

infusing a contrast medium through a second lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide substantially within said first lumen of said catheter such that said duct may be visualized through the use of said contrast medium without requiring the removal of said wire guide from said duct or said first lumen; and

advancing an instrument through a third lumen of said catheter and through said distal opening of said third lumen and along said duct while maintaining said wire guide substantially within said first lumen of said catheter, wherein said instrument comprises at least one of a stone extractor, a papillotome, forceps, a biopsy cutter, a cytology brush, a snare and a basket.

12. A method of study of a duct of a patient using a catheter having at least three lumens, each having a distal opening at a distal end of said catheter, a first lumen of said catheter having a wire guide threaded therethrough and a second lumen of said catheter having an instrument threaded therethrough, comprising the steps of:

threading said catheter and said wire guide and instrument through an endoscope and into said duct to a desired position;

infusing a contrast medium through a third lumen of said catheter to visualize said duct through the use of said contrast medium while maintaining said wire guide and instrument substantially within said first and second lumens of said catheter such that said duct may be visualized through the use of said contrast medium without requiring the removal of said wire guide or said instrument from said duct or said first or second lumens; and

advancing said instrument through the distal opening of said second lumen of said catheter while maintaining said wire guide substantially within said first lumen of said catheter, wherein said instrument comprises at least one of a stone extractor, a papillotome, forceps, a biopsy cutter, a cytology brush, a snare and a basket.

13. A method for replacing a stent within a biliary tract using a catheter having at least three lumens, comprising the steps of:

inserting a wire guide through an endoscope and into a biliary tract;

threading a first lumen of said catheter said wire guide to a predetermined position proximal to a stent requiring replacement in said biliary tract, said catheter having a distal end carrying a replacement stent;

infusing a tracer dye through a second lumen of said catheter for visualization of said stent to be replaced;

advancing a snare through a third lumen of said catheter for snaring said stent to be replaced;

withdrawing said snare until said stent to be replaced is disposed within the intestinal tract;

releasing said stent to be replaced within said intestinal tract; and

readvancing said catheter to position said replacement stent at a replacement position within said biliary tract.

14. The method of claim 13, wherein said catheter has a reduced diameter distal portion for supporting said replacement stent, and the method further comprises withdrawing said catheter to cause said replacement stent to slide off of said distal portion of said catheter at said replacement position.

15. A method for replacing a stent within a biliary tract using a catheter having at least three lumens and a distal end carrying a replacement stent, a first lumen of said catheter having a wire guide threaded therethrough, comprising the steps of:

inserting said catheter and wire guide through an endoscope and into a biliary tract to a predetermined position proximal to a stent requiring replacement;

infusing a contrast medium through a second lumen of said catheter for visualization of said stent to be replaced while maintaining said wire guide in said first lumen of said catheter;

advancing a snare through a third lumen of said catheter for snaring said stent to be replaced while maintaining said wire guide in said first lumen of said catheter;

withdrawing said snare until said stent to be replaced is disposed in the intestinal tract while maintaining said wire guide in said first lumen of said catheter;

releasing said stent to be replaced within said intestinal tract;

readvancing said catheter to position said replacement stent at a replacement position within said biliary tract; and

withdrawing said catheter to cause said replacement stent to slide off of said distal end of said catheter at said replacement position.

16. A method for replacing a stent within a biliary tract using a catheter having at least three lumens and a distal end carrying a replacement stent, a first lumen of said catheter having a stiffening element threaded therethrough, comprising the steps of:

inserting said catheter and stiffening element through an endoscope and into a biliary tract to a predetermined position proximal to a stent requiring replacement;

infusing a contrast medium through a second lumen of said catheter for visualization of said stent to be replaced while maintaining said stiffening element in said first lumen of said catheter;

advancing a snare through a third lumen of said catheter for snaring said stent to be replaced while maintaining said stiffening element in said first lumen of said catheter;

withdrawing said snare until said stent to be replaced is disposed in the intestinal tract while maintaining said stiffening element in said first lumen of said catheter;

releasing said stent to be replaced within said intestinal tract;

readvancing said catheter to position said replacement stent at a replacement position within said biliary tract; and

withdrawing said catheter to cause said replacement stent to slide off of said distal end of said catheter at said replacement position.