Sphincterotomy method and device having controlled bending and orientation

• US 5,024,617 A
• Filed: 03/03/1989
• Issued: 06/18/1991
• Est. Priority Date: 03/03/1989
• Status: Expired due to Term

• Current Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Karpiel, John
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/318,724
• Time in Patent Office: 837 Days
• Field of Search: 128/772, 604/95, 604/280, 604/282, 606/39, 606/45, 606/46, 606/47, 606/113, 606/129, 606/170
• US Class Current: 606/47
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A sphincterotome, such as a papillotome, is disclosed for surgical cutting using an electrically conductive cutter wire. The sphincterotome includes a multi-lumen tubular member, with one lumen having an electrical conductor disposed therein, and the other lumen having a reinforcing wire disposed therein. The reinforcing wire is preferably rectangular in cross-section, providing a greater moment of inertia in a resisting axis than in a bending axis. Accordingly, the cutting edge of the cutting wire may be oriented to the 12 o'"'"'clock position of the papillary orifice to avoid injury to the duodenal wall or pancreatic duct in the patient, and to maintain the cutting edge in a predetermined cutting plane. Fluoroscopic indicating stripes may be provided at the distal end of the sphincterotome. A method of use and method of fabrication of the present invention is also disclosed.

Claims

1. A medical sphincterotome, comprising:

an elongated multi-lumen tubular member having a proximal end and a distal end and being sized to be received in an endoscopic lumen;

a cutter having a cutting edge located along said distal end of said tubular member and oriented generally longitudinally with respect to said tubular member, wherein said cutting edge is movable in a cutting plane to cut a patient'"'"'s sphincter, said cutter being connected to a conductor disposed in a first longitudinal lumen in said tubular member;

a second longitudinal lumen along the length of said tubular member for receiving reinforcing means; and

reinforcing means disposed in said second longitudinal lumen for resisting movement of said cutting edge out of said cutting plane, said reinforcing means having a first cross-sectional moment of inertia with respect to a bending axis normal to said cutting plane, said reinforcing means further having a second cross-sectional moment of inertia with respect to a resisting axis lying along said cutting plane and generally perpendicular to said tubular member, wherein said second moment of inertia is greater than said first moment of inertia along said distal end to resist bending out of said cutting plane to provided controlled cutting of the patient'"'"'s sphincter along said cutting plane.

2. The sphincterotome of claim 1 wherein said reinforcing means comprises a cross-sectionally rectangular wire.

3. The sphincterotome of claim 2 wherein said second longitudinal lumen has a rectangular cross-section corresponding to the cross-section of said reinforcing means.

4. The sphincterotome of claim 3 wherein said first longitudinal lumen has an opening at said distal end of said tubular member.

5. The sphincterotome of claim 4 and further comprising indicating means at said distal end of said tubular member for providing visual indication of the position of said distal end in the patient.

6. The sphincterotome of claim 5 wherein said cutter comprises a wire bowed between first and second locations at said distal end outside of said first longitudinal lumen.

7. The sphincterotome of claim 1 wherein said second longitudinal lumen has a rectangular cross-section.

8. The sphincterotome of claim 1 wherein said first longitudinal lumen has an opening at said distal end of said tubular member.

9. The sphincterotome of claim 1 and further comprising indicating means at said distal end of said tubular member for providing visual indication of the position of said distal end in the patient.

10. The sphincterotome of claim 1 wherein said cutter comprises a wire bowed between first and second locations at said distal end outside of said first longitudinal lumen.

11. A method of surgically cutting a patient'"'"'s sphincter, comprising the steps of:

positioning an endoscope near the sphincter to allow viewing of the sphincter;

extending a sphincterotome out of an opening in said endoscope and into engagement with the sphincter, said sphincterotome comprising;

an elongated multi-lumen tubular member having a proximal end and a distal end and being sized to be received in an endoscopic lumen;

a cutter having a cutting edge located along said distal end of said tubular member and oriented generally longitudinally with respect to said tubular member, wherein said cutting edge is movable in a cutting plane to cut the patient'"'"'s sphincter, said cutter being connected to a conductor disposed in a first longitudinal lumen in said tubular member;

a second longitudinal lumen along the length of said tubular member for receiving reinforcing means; and

reinforcing means disposed in said second longitudinal lumen for resisting movement of said cutting edge out of said cutting plane, said reinforcing means having a first cross-sectional moment of inertia with respect to a bending axis normal to said cutting plane, said reinforcing means further having a second cross-sectional moment of inertia with respect to a resisting axis lying along said cutting plane and generally perpendicular to said tubular member, wherein said second moment of inertia is greater than said first moment of inertia along said distal end to resist bending out of said cutting plane;

orienting said cutting edge and said reinforcing means so that said cutting plane is oriented radially with respect to a center of the sphincter; and

energizing said cutter with said cutting edge in said cutting plane to cut the sphincter radially outward of said center of the sphincter while said reinforcing means resists movement of said cutting edge out of said cutting plane.

12. The method of claim 11 wherein said reinforcing means comprises a cross-sectionally rectangular wire.

13. The method of claim 11 wherein said sphincter is the Sphincter of Oddi in the Papilla of Vater.