Multi-lumen endoscopic catheter

• US 5,788,681 A
• Filed: 10/15/1996
• Issued: 08/04/1998
• 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:
  US08/730,343
• Time in Patent Office: 658 Days
• Field of Search: 604/96, 604/102, 604/264, 604/280, 606/167, 606/169, 606/45, 606/46
• US Class Current: 604/523
• 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 catheter assembly intended for advancement and manipulation through the accessory channel of an endoscope into a body passage within the gastrointestinal system, said catheter comprising:

a substantially cylindrical, flexible catheter body having a uniform outer diameter throughout its entire length;

said catheter body having a beveled distal tip, a proximal end and at least first and second independent lumens extending lengthwise thereof, each said lumen having an entry port at the proximal end of the catheter body and an exit port at the beveled distal tip,each said exit port facing axially of the catheter body, and a third independent lumen extending lengthwise thereof, the third independent lumen having an exit port disposed proximally from the distal tip; and

wherein said beveled distal tip comprises a first, acutely angled, planar portion and second planar portion at a distal end of the first, said second planar portion being perpendicularly disposed with respect to the long axis of the catheter body, wherein one of said exit ports exits substantially through the first planar portion and the other of said lumens exits substantially through the second planar portion.

2. A catheter assembly according to claim 1, wherein the exit port of the first independent lumen extends through the first planar portion, and the exit port of the second independent lumen is in said second planar portion.

3. A catheter assembly according to claim 2, wherein the exit port of the first independent lumen is spaced less than one-quarter inch from the second planar portion.

4. A catheter assembly for advancement and manipulation through the accessory channel of an endoscope into a body passage within the gastrointestinal system, the catheter assembly comprising:

an elongate catheter body having a proximal end and a distal end having a distal tip, the distal tip having an planar portion disposed perpendicular to the long axis of the catheter body, and a beveled planar portion extending proximally from the planar portion;

a first elongate lumen extending from the proximal end to the distal end of the catheter body, the first elongate lumen configured for receiving a guide wire and having an entry port at the proximal end of the catheter body and an exit port at the distal tip of the catheter body;

a second elongate lumen extending from the proximal end to a port in the distal tip of the catheter body, the second elongate lumen being configured for injection of tracer dye out the port in the distal tip of the elongate catheter body, such that tracer dye may be released from the distal tip of the elongate catheter body while a guide wire remains in the first lumen; and

a third elongate lumen extending from the proximal end of the catheter body to a position adjacent the distal end of the catheter body, the third lumen being configured for conducting a procedure other than guide wire placement or trace dye injection; and

wherein catheter assembly further comprises an inflatable balloon disposed about the catheter body proximally from the distal end, and wherein the catheter assembly includes a port disposed at the end of the third lumen and exiting into the balloon such that injection of a fluid into the third lumen inflates the balloon.

5. A catheter assembly for advancement and manipulation through the accessory channel of an endoscope into a body passage within the gastrointestinal system, the catheter assembly comprising:

an elongate catheter body having a proximal end and a distal end having a distal tip, the distal tip having an planar portion disposed perpendicular to the long axis of the catheter body, and a beveled planar portion extending proximally from the planar portion;

a first elongate lumen extending from the proximal end to the distal end of the catheter body, the first elongate lumen configured for receiving a guide wire and having an entry port at the proximal end of the catheter body and an exit port at the distal tip of the catheter body;

a second elongate lumen extending from the proxi catheter body, the second elongate lumen being configured for injection of tracer dye out the port in the distal tip of the elongate catheter body, such that tracer dye may be released from the distal tip of the elongate catheter body while a guide wire remains in the first lumen; and

a third elongate lumen extending from the proximal end of the catheter body to a position adjacent the distal end of the catheter body, the third lumen being configured for conducting a procedure other than guide wire placement or trace dye injection; and

wherein the third lumen extends to a position adjacent the distal end of the catheter body, and wherein an electrosurgical cutting element forming a sphinctertome/papillotome is disposed in the third lumen.

6. The catheter assembly of claim 5, wherein the sphinctertome/papillotome is permanently disposed in the third lumen.

7. A catheter assembly intended for advancement and manipulation through the accessory channel of an endoscope into a body passage within the gastrointestinal system, said catheter assembly comprising:

a substantially cylindrical, flexible catheter body;

said catheter body having a proximal end and a beveled distal tip and at least two independent lumens extending lengthwise therebetween, each said lumen having an entry port at the proximal end of the catheter body and an exit port at said distal tip, each said exit port facing generally axially of the catheter body; and

wherein said catheter body further comprises a third independent lumen extending lengthwise thereof, an inflatable, radially expandable dilation balloon disposed adjacent said distal tip and an exit port for said third independent lumen establishing communication with the interior of the balloon.

8. A catheter assembly intended for advancement and manipulation through the accessory channel of an endoscope into a body passage within the gastrointestinal system, said catheter assembly comprising:

a substantially cylindrical, flexible catheter body;

said catheter body having a proximal end and a beveled distal tip and at least two independent lumens extending lengthwise therebetween, each said lumen having an entry port at the proximal end of the catheter body and an exit port at said distal tip, each said exit port facing generally axially of the catheter body; and

wherein said beveled distal tip comprises a first, acutely angled, planar portion and a second planar portion distally of the first, acutely angled planar portion and in disposed in contact with the first acutely angled planar portion, said second planar portion being perpendicularly disposed with respect to the long axis of the catheter body, wherein one of said exit ports exits substantially through the first planar portion and the other of said lumens exits substantially through the second planar portion.

9. A catheter assembly according the claim 8, wherein the catheter body further comprises a third, accessory lumen extending lengthwise through said catheter body, a third exit port located adjacent said distal tip for said third, accessory lumen, said third, accessory lumen being independent of said other lumens and being sized for passage of a stone extractor.

10. A catheter assembly according the claim 8, wherein the catheter body further comprises a third, accessory lumen extending lengthwise through said catheter body to a third exit port located adjacent said distal tip for said accessory lumen, said accessory lumen being independent of said other lumens and being configured for receiving a papillotome/sphinctertome.

11. A catheter assembly according to claim 8, wherein the catheter body further comprises a third, accessory lumen extending lengthwise therethrough to a third exit port located adjacent said distal tip for said third, accessory lumen, said third, accessory lumen being independent of said other lumens and being configured for passage of grasping forceps.

12. A catheter assembly according to claim 8, wherein the catheter body further comprises a third, accessory lumen extending lengthwise therethrough to a third exit port located adjacent said distal tip for said third, accessory lumen, said third, accessory lumen being independent of said other lumens and being configured for passage of a biopsy cutter.

13. A catheter assembly according to claim 8, wherein the catheter body further comprises a third, accessory lumen extending lengthwise therethrough to a third exit port located adjacent said distal tip in communication with said third, accessory lumen, said third, accessory lumen being independent of said other lumens and being configured for passage of a cytology brush.

14. A catheter assembly according the claim 8, wherein the catheter body further comprises a third, accessory lumen extending lengthwise through said catheter body to a position adjacent distal tip, said accessory lumen being independent of said other lumens and having an electrosurgical cutting instrument forming a sphinctertome/papillotome disposed therein.

15. A catheter assembly according to claim 14, wherein the sphinctertome/papillotome is permanently disposed in the third, accessory lumen.

16. A catheter for advancement through the accessory channel of an endoscope into a body passage within the gastrointestinal system, said catheter comprising:

a substantially cylindrical, flexible catheter body having a substantially uniform outer diameter extending throughout its length;

said catheter body having a proximal end and a distal tip and at least three independent lumens extending lengthwise thereof, each said lumen having an entry port at the proximal end thereof and at least a first lumen and a second lumen of said at least three independent lumens having axially facing exit ports disposed in said distal tip, the first lumen being configured for receiving a wire guide and the second lumen being configured for injection of contrast fluid, and

wherein a third lumen of the at least three lumens has an electrosurgical instrument configured to form a sphinctertome/papillotome disposed therein.

17. A catheter according to claim 16, wherein the sphinctertome/papillotome is permanently disposed within the third lumen.

18. A catheter assembly for advancement and manipulation through the accessory channel of an endoscope into a body passage within the gastrointestinal system, the catheter assembly comprising:

an elongate catheter body having a proximal end and a distal end;

a first elongate lumen extending from the proximal end to the distal end of the catheter body, the first elongate lumen configured for receiving a guide wire and having an entry port at the proximal end of the catheter body and an exit port the distal end of the catheter body;

a second elongate lumen extending from the proximal end to the distal end of the catheter body, the second elongate lumen being configured for injection of tracer dye out the distal end of the elongate catheter body, such that tracer dye may be released from the distal end of the elongate catheter body while a guide wire is disposed in the first lumen; and

a third elongate lumen extending from the proximal end of the catheter body toward the distal end of the catheter body, the third lumen having an electrosurgical tissue cutting instrument disposed therein.

19. The catheter assembly of claim 18, wherein the electrosurgical cutting instrument comprises a papillotome/sphinctertome.

20. The catheter assembly of claim 19, wherein the papillotome/sphinctertome is permanently disposed in the third lumen.

21. The catheter assembly of claim 20, wherein the first and second lumens extend continuously and exit through independent axially facing ports in the distal tip of the catheter body.

22. The catheter assembly of claim 20, wherein the catheter body is substantially cylindrical and has a substantially uniform outer diameter extending throughout its length.

23. A catheter assembly for advancement and manipulation through the accessory channel of an endoscope into a body passage, the catheter assembly comprising:

an elongate catheter body having a proximal end and a distal end having a distal tip;

first, second and third lumens formed within the catheter body, each of the first, second and third lumens extending from respective ports formed adjacent the proximal end and toward the distal end, the first and second lumens terminating in ports at the distal tip; and

electrosurgical tissue cutting means disposed in the third lumen for selectively cutting tissue, the tissue cutting means forming a papillotome/sphinctertome.