Multi-lumen endoscopic catheter

• US 5,843,028 A
• Filed: 08/30/1996
• Issued: 12/01/1998
• Est. Priority Date: 05/11/1992
• Status: Expired due to Term

• Current Assignee: Medical Instruments Development Incorporated
• Original Assignee: Medical Innovations Corporation (Kimberly-Clark Corporation)
• Inventors: Jacob, Harold, Leighton, David F., Weaver, George W., Holsinger, Damond C.
• Primary Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/706,311
• Time in Patent Office: 823 Days
• Field of Search: 604/49, 604/52-53, 604/54, 604/96, 604/102, 604/280, 606/108, 606/167, 606/45, 606/46
• US Class Current: 604/514
• 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 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• 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
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: G01R 19/10 Measuring sum, difference or ratio
• CPC Class Codes: H04M 3/30 for subscriber's lines , for the local loop
• CPC Class Codes: H04Q 11/045 Selection or connection testing arrangements
• CPC Class Codes: H04Q 2213/1316 Service observation, testing
• CPC Class Codes: H04Q 2213/13209 ISDN
• CPC Class Codes: H04Q 2213/13305 Transistors, semiconductors in general
• CPC Class Codes: H04Q 2213/1332 Logic circuits
• CPC Class Codes: H04Q 2213/13322 Integrated circuits

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 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 tip of said catheter, and a third lumen communicating with a balloon disposed proximal to said distal tip of said catheter, a first lumen of said catheter having a wire 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 release contrast fluid from the distal tip of the catheter and 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.

2. The method of claim 1, wherein the method comprises, more specifically, selecting a catheter wherein the first and second lumens end in independent axially facing ports in the distal end of the catheter.

3. A method of dilating a duct of a patient using a catheter having at least three lumens, a first of said lumens having a distally facing distal opening at a distal tip of said catheter, a second of said lumens having a generally distal facing distal opening adjacent the distal tip of the 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 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 release contrast fluid from the catheter and visualize said duct distally of the balloon 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.

4. The method according to claim 3, wherein the method further comprises releasing contrast fluid into the duct through the second lumen while the balloon is inflated.

5. 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 tip of said catheter, and a third lumen communicating with a balloon disposed proximal to said distal tip 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.

6. The method according to claim 5, wherein the method further comprises releasing contrast fluid into the duct through the second lumen while the balloon is inflated.

7. A method of visualizing a duct of the biliary tree, the method comprising:

(a) selecting a catheter having a first lumen configured for receiving a wire guide, a second lumen configured for injecting contrast fluid, the first and second lumens terminating at the distal end of the catheter, and a third lumen configured for receiving a cutting instrument;

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

(c) infusing a contrast medium through a second lumen of said catheter to release contrast fluid from the catheter and visualize said duct distally of the catheter.

8. The method according to claim 7, further comprising actuating a cutting instrument in the third lumen to cut tissue.

9. The method according to claim 8, wherein the method comprises, more specifically, using a papillotome/sphincterotome in the third lumen to cut tissue.

10. The method according to claim 7, wherein the method comprises, more specifically, selecting a catheter having a papillotome permanently disposed in the third lumen.

11. A method of visualizing a duct of the biliary tree, the method comprising:

(a) selecting a catheter having a first lumen configured for receiving a wire guide, a second lumen configured for injecting contrast fluid, the first and second lumens terminating at the distal tip of the catheter, and a third lumen configured for receiving a cutting instrument;

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

(c) infusing a contrast medium through a second lumen of said catheter to release contrast fluid from the distal tip of the catheter and visualize said duct distally of the catheter.

12. The method according to claim 11, further comprising actuating a cutting instrument in the third lumen to cut tissue.

13. The method according to claim 12, wherein the method comprises, more specifically, using a papillotome in the third lumen to cut tissue.

14. The method according, to claim 11, wherein the method comprises, more specifically, selecting a catheter having a papillotome permanently disposed in the third lumen.

15. A method of visualizing a duct of the biliary tree, the method comprising:

(a) selecting a catheter having a first lumen configured for receiving a wire guide, a second lumen configured for injecting contrast fluid, the first and second lumens each terminating in an independent axially facing port in the distal end of the catheter, and a third lumen configured for receiving a cutting instrument;

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

(c) infusing a contrast medium through a second lumen of said catheter to release contrast fluid from the distal tip of the catheter and visualize said duct distally of the catheter.

16. The method according to claim 15, further comprising actuating a cutting instrument in the third lumen to cut tissue.

17. The method according to claim 15, wherein the method comprises, more specifically, selecting a catheter having a papillotome disposed in the third lumen and using the papillotome to cut tissue.