Steerable sphincterotome and methods for cannulation, papillotomy and sphincterotomy

• US 6,676,659 B2
• Filed: 08/14/2001
• Issued: 01/13/2004
• Est. Priority Date: 08/14/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Mark L., Hutchins, John E.
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US09/928,655
• Publication Number:
  US 20020095146A1
• Time in Patent Office: 882 Days
• Field of Search: 606/39, 606/127, 606/128, 606/167, 606/170, 606/129, 606/159, 606/47, 604/22, 604/105-109, 600/567, 600/585, 128/898
• US Class Current: 606/47
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2018/00535 Biliary tract
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

The present invention relates to methods and devices for performing endoscopic cannulation, papillotomy and sphincterotomy and similar procedures. According to the present state of the art, endoscopic cannulation of the common bile duct and papillotomy and similar procedures are accomplished by advancing the device into an endoscope/duodenoscope so that the distal tip of the device exits the endoscope adjacent the sphincter muscles at the Papilla of Vater. The endoscope mechanisms are then manipulated to orient the distal tip of the device to the desired position for proper cannulation of the duct. Due to inconsistencies in, for example, the sphincterotome, anatomy, and endoscope manipulation, it is difficult to accurately and consistently position the sphincterotome for proper cannulation. The steerable sphincterotome of the present invention allows the physician to control the position of the distal tip of the device independently of the endoscope and adjust for inconsistencies in the device and the anatomy. According to the present invention, the handle to which the cutting wire is attached is freely rotatable relative to the catheter. The handle, secured to the cutting wire but rotatable relative to the shaft of the catheter, provides a mechanism to rotate the wire, transmitting the force to rotate the device tip. With the handle rotating independently of the shaft at the proximal end, the force can be applied directly to the distal tip without twisting the entire shaft. Also a rotation lock to maintain the orientation of the tip and/or a rotation marking, to indicate the amount of rotation may be included.

Claims

1. An apparatus for use in a treatment modality including an enlargement procedure to be performed within a patient, said apparatus including a catheter for being directed through internal passageways in the patient, said catheter having proximal and distal ends, and proximal and distal portions adjacent to said proximal and distal ends respectively, and a first and at least second generally parallel lumens, said lumens extending between said proximal and distal portions, and a cutting wire for performing the enlargement procedure extending through said second lumen for operating at said distal portion in response to manipulations at said proximal end, said cutting wire having a distal end attached to said catheter at the distal end of said second lumen, a portion thereof external to said catheter along a length coextensive with a portion of said distal portion of said catheter and a handle for operating said cutting wire from a point proximal of said catheter, the improvement comprising:

a rotatable coupling attaching said handle to said catheter allowing said handle to rotate relative to said proximal end of said catheter while engaging and rotating a proximal end of said cutting wire whereby said distal portion of said catheter rotates as a result of said rotation of said handle.

2. The apparatus of claim 1 further comprising:

a rotation lock which inhibits further rotation of said handle relative to said proximal end of said catheter.

3. The apparatus of claim 1, further comprising:

a rotation indicator configured to indicate an amount of rotation of said handle relative to said proximal end of said catheter.

4. The apparatus of claim 3, herein said rotation indicator comprises a visual indicator of said amount of rotation.

5. The apparatus of claim 4, herein said visual indicator comprises an index marking and a corresponding scale marking providing an indication of said amount of rotation.

6. The apparatus of claim 3, herein said rotation indicator comprises a device providing an audible indication in response to aid rotation of said handle relative to said proximal end of said catheter.

7. A method of cutting tissue in a body passage comprising selecting a catheter having first lumen configured for receiving a wire guide, a second lumen configured for receiving an electrosurgical cutting wire, positioning said catheter in said passage at a desired position using an endoscope, actuating the electrosurgical cutting wire in the second lumen, the improvement comprising:

orientating said electrosurgical cutting wire by rotating a handle relative to a proximal end of said catheter, and where said step of rotating said handle causes a rotation of a proximal end of said cutting wire affixed to said handle whereby said cutting wire is caused to rotate within said second lumen, and wherein a distal end of said cutting wire is caused to rotate by a twisting of a portion of said cutting wire intermediate said proximal and said distal portions of said cutting wire.

8. A method of cutting tissue in a body passage comprising selecting a catheter having first lumen configured for receiving a wire guide, a second lumen configured for receiving an electrosurgical cutting wire, positioning said catheter in said passage at a desired position using an endoscope, actuating the electrosurgical cutting wire in the second lumen, the improvement comprising:

orientating said electrosurgical cutting wire by rotating a handle relative to a proximal end of said catheter, and

indicating an amount of rotation of said handle relative to said proximal end of said catheter through the use of a rotation indicator, where said step of indicating includes a visual indication of said amount of rotation, where said visual indication includes an index marking and a corresponding scale marking providing an indication of said amount of rotation.

9. A method of cutting tissue in a body passage comprising selecting a catheter having first lumen configured for receiving a wire guide, a second lumen configured for receiving a electrosurgical cutting wire, positioning said catheter in said passage at a desired position using an endoscope, actuating the electrosurgical cutting wire in the second lumen, the improvement comprising:

orientating said electrosurgical cutting wire by rotating a handle relative to a proximal end of said catheter; and

indicating an amount of rotation of said handle relative to said proximal end of said catheter through the use of a rotation indicator, where said step of indicating includes an audible indicator provided by a device in response to said rotation of said handle relative to said proximal end of said catheter.

10. A catheter handle comprising:

a rotatable coupling configured to allow free rotation of a proximal end of a catheter;

a clamping member configured to engage a proximal end of a device extending through a lumen formed in said catheter whereby rotation of said handle causes rotation of a proximal end of said device in said lumen; and

a rotation indicator configured to indicate an amount of rotation of said handle relative to said proximal end of said catheter, wherein said rotation indicator comprises a visual indicator of said amount of rotation, and said visual indicator comprising an index marking and a corresponding scale marking providing an indication of said amount of rotation.

11. A catheter assembly, comprising:

a catheter having at lest two lumens, and a handle comprising;

a rotatable coupling configured to allow free rotation of a proximal end of said catheter; and

a clamping member configured to engage a proximal end of a device extending through a lumen in said catheter whereby rotation of said handle causes rotation of a proximal end of said device in said lumen, and

a rotation indicator configured to indicate an amount of rotation of said handle relative to said proximal end of said catheter, wherein said rotation indicator comprises a device providing an audible indication in response to said rotation of said handle relative to said proximal end of said catheter.