Method and apparatus for electrosurgically obtaining access to the biliary tree and placing a stent therein

• US 5,536,248 A
• Filed: 11/01/1994
• Issued: 07/16/1996
• 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:
  US08/332,836
• Time in Patent Office: 623 Days
• Field of Search: 604/49, 604/52-54, 604/280, 606/45, 606/46, 606/108, 606/167
• US Class Current: 604/506
• 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 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
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A method of electrosurgically obtaining access to the biliary tree of a patient and visualizing a duct thereof using a catheter having a least a first lumen and a second lumen. The first lumen has a needle-knife disposed therein, which knife may be moved between a deployed position and a sheathed position and is in electrical communication with a power source. The method includes the steps of (1) inserting the catheter through an endoscope and into the duodenum of a patient proximal to the entrance to the common bile duct, (2) deploying the needle-knife, (3) manipulating the needle-knife and applying current thereto to incise tissue proximal to the entrance to the common bile duct, (4) withdrawing the needle-knife into the sheathed position, (5) advancing the catheter into the common bile duct to a desired location within said duct; and (6) infusing a contrast medium through a second lumen of the catheter to visualize the common bile duct through the use of the contrast medium while the needle-knife remains in the first lumen of the catheter.

Claims

1. A method of electrosurgically obtaining access to a duct of a patient using a catheter having at least a first lumen and a second lumen defined therethrough, each lumen terminating in an opening defined at a distal end of said catheter, said first lumen of said catheter having an elongated sheath threaded therethrough, said sheath having a needle-knife disposed therein, said needle-knife being connected to a deployment means at a proximal end of said sheath for extending and retracting said needle-knife between a deployed position and a sheathed position relative to a distal end of said sheath, said needle-knife electrically communicating with a power source, said method comprising:

inserting said catheter containing said needle-knife and said sheath through an endoscope and into a position proximal to an entrance to a duct of the patient;

deploying said needle-knife from said sheathed position relative to said distal end of said sheath;

manipulating said needle-knife and applying current thereto to incise tissue proximal to said entrance to said duct;

withdrawing said needle-knife into said sheathed position relative to said distal end of said sheath while said sheath remains in said first lumen of said catheter;

advancing said catheter into said duct to a desired location within said duct while said sheath remains in said first lumen of said catheter; and

infusing a contrast medium through said second lumen of said catheter to visualize said duct while said sheath and said needle-knife remain in said first lumen of said catheter.

2. The method of claim 1, further comprising the step of withdrawing said sheath and said needle-knife through said first lumen of said catheter and then threading a wire guide through said first lumen of said catheter while said catheter remains in said duct.

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

advancing said wire guide through said opening defined in said distal end of said catheter and along said duct;

further advancing said catheter along said wire guide to a second desired location within said duct; and

infusing said contrast medium through said second lumen of said catheter to visualize said duct while said wire guide remains in said first lumen of said catheter.

5. The method of claim 1, further comprising the step of withdrawing said needle-knife through said first lumen of said catheter and then threading a wire guide through said first lumen of said catheter while said catheter remains in said common bile duct.

6. The method of claim 5, further comprising the steps of:

advancing said wire guide through said opening defined in said distal end of said catheter and along said common bile duct;

further advancing said catheter along said wire guide to a second desired location within said common bile duct; and

infusing said contrast medium through said second lumen of said catheter to visualize said duct while said wire guide remains in said first lumen of said catheter.

4. A method of electrosurgically obtaining access to the biliary tree of a patient and visualizing a duct thereof using a catheter having at least a first lumen and a second lumen defined therethrough, each lumen terminating in an opening defined at a distal end of said catheter, said first lumen of said catheter having a needle-knife disposed therein, said needle-knife being connected to a deployment means at a proximal end of said catheter for extending and retracting said needle-knife between a deployed position and a sheathed position relative to said distal end of said catheter, said needle-knife electrically communicating with a power source, said method comprising the steps of:

inserting said catheter and said needle-knife in said sheathed position through an endoscope and into the duodenum of the patient proximal to the entrance to the common bile duct;

deploying said needle-knife from said sheathed position relative to said distal end of said catheter;

manipulating said needle-knife and applying current thereto to incise tissue proximal to said entrance to said common bile duct;

withdrawing said needle-knife into said sheathed position relative to said distal end of said catheter;

advancing said catheter into said common bile duct to a desired location within said duct; and

infusing a contrast medium through said second lumen of said catheter to visualize said common bile duct through the use of said contrast medium while said needle-knife remains in said first lumen of said catheter.

7. A method of electrosurgically obtaining access to a duct of a patient using a catheter having at least a first lumen and a second lumen defined therethrough, each lumen terminating in an opening defined at a distal end of said catheter, said first lumen of said catheter having an elongated sheath threaded therethrough, said sheath having a needle-knife disposed therein, said needle-knife being connected to a deployment means at a proximal end of said sheath for extending and retracting said needle-knife between a deployed position and a sheathed position relative to a distal end of said sheath, said needle-knife electrically communicating with a power source, said method comprising:

inserting said catheter containing said needle-knife and said sheath through an endoscope and into a position proximal to an entrance to a duct of the patient;

deploying said needle-knife from said sheathed position relative to said distal end of said sheath;

manipulating said needle-knife and applying current thereto to incise tissue proximal to said entrance to said duct;

withdrawing said sheath and said needle-knife through said first lumen of said catheter and then threading a wire guide through said first lumen of said catheter while said catheter remains in said position proximal to said entrance of said duct;

advancing said wire guide through said opening defined in said distal end of said catheter and along said duct;

advancing said catheter over said wire guide to a desired location within said duct; and

infusing a contrast medium through said second lumen of said catheter to visualize said duct while said wire guide remains in said first lumen of said catheter.

8. A method for placing a stent in a duct of a patient using a first catheter having a proximal end and a distal end, said first catheter having a catheter connector at said proximal end thereof and at least a first lumen and a second lumen, said first lumen having a wire guide threaded therethrough;

said method further using a second catheter having at least one lumen defined therethrough for enabling said second catheter to be threaded over said first catheter to advance said stent over said first catheter;

said method further using a catheter cutting means for cutting said first catheter near said proximal end of said first catheter to separate said catheter connector from first said catheter, said method comprising the steps of;

inserting said first catheter and said wire guide through an endoscope and into a duct of the patient;

infusing a contrast medium through a second lumen of said first catheter and into said duct while said wire guide remains in said first lumen of said first catheter such that said duct may be visualized through the use of said contrast medium;

cutting said first catheter near said proximal end of said first catheter with said catheter cutting means to sever said catheter connector from said first catheter while said first catheter remains in said duct;

removing said catheter connector from said wire guide; and

threading said stent over said wire guide and said first catheter with said second catheter by threading said second catheter over said wire guide and said first catheter to advance said stent to a desired location within said duct.

9. A method for placing a biliary stent around a biliary calculus in a biliary duct of a patient using a first catheter having a proximal end and a distal end, said first catheter having a catheter connector attached to said proximal end thereof and a least a first lumen and a second lumen, said first lumen having a wire guide threaded therethrough;

said method further using a second catheter having at least one lumen defined therethrough for enabling said second catheter to be threaded over said first catheter to advance said stent over said first catheter;

said method further using a catheter cutting means for cutting said first catheter near said proximal end of said first catheter to sever said catheter connector from said first catheter, said method comprising the steps of;

inserting said first catheter and said wire guide through an endoscope and into a biliary duct of the patient containing said biliary calculus;

infusing a contrast medium through a second lumen of said first catheter and into said biliary duct proximate to said biliary calculus, such that said biliary calculus may be visualized through the use of said contrast medium;

cutting said first catheter near said proximal end of said first catheter with said catheter cutting means to sever said catheter connector from said first catheter while said first catheter remains in said biliary duct;

removing said catheter connector from said wire guide; and

threading said biliary stent over said wire guide and said first catheter with said second catheter by threading said second catheter over said wire guide and first catheter to place said biliary stent around said visualized biliary calculus.

10. A method for placing a stent around a pancreatic obstruction in a pancreatic duct of a patient using a first catheter having a proximal end and a distal end, said first catheter having a catheter connector attached to said proximal end thereof and a least a first lumen and a second lumen, said first lumen having a wire guide threaded therethrough;

said method further using a second catheter having at least one lumen defined therethrough for enabling said second catheter to be threaded over said first catheter to advance said stent over said first catheter;

said method further using a catheter cutting means for cutting said first catheter near said proximal end of said first catheter to sever said catheter connector from said first catheter, comprising the steps of;

inserting said first catheter and said wire guide through an endoscope and into a pancreatic duct of the patient containing said pancreatic obstruction;

infusing a contrast medium through a second lumen of said first catheter and into said pancreatic duct proximate to said pancreatic obstruction, such that said pancreatic obstruction may be visualized through the use of said contrast medium;

cutting said first catheter near said proximal end of said first catheter with said catheter cutting means to sever said catheter connector from said first catheter while said first catheter remains in said pancreatic duct; and

removing said catheter connector from said wire guide; and

threading said stent over said wire guide and said first catheter with said second catheter by threading said second catheter over said wire guide and said first catheter to place said stent around said visualized pancreatic obstruction.

11. A method for placing a stent around a cystic obstruction in a cystic duct of a patient using a first catheter having a proximal end and a distal end, said first catheter having a catheter connector attached to said proximal end thereof and a least a first lumen and a second lumen, said first lumen having a wire guide threaded therethrough;

said method further using a second catheter having at least one lumen defined therethrough for enabling said second catheter to be threaded over said first catheter to advance said stent over said first catheter;

said method further using a catheter cutting means for cutting said first catheter near said proximal end of said first catheter to sever said catheter connector from said first catheter, comprising the steps of;

inserting said first catheter and said wire guide through an endoscope and into a cystic duct of the patient containing said cystic obstruction;

infusing a contrast medium through a second lumen of said first catheter and into said cystic duct proximate to said cystic obstruction, such that said cystic obstruction may be visualized through the use of said contrast medium;

cutting said first catheter near said proximal end of said first catheter with said catheter cutting means to sever said catheter connector from said first catheter while said first catheter remains in said cystic duct;

removing said catheter connector from said wire guide; and

threading said stent over said wire guide and said first catheter with said second catheter by threading said second catheter over said wire guide and said first catheter to place said stent around said visualized cystic obstruction.