Sphincterotome with deflectable cutting plane and method of using the same

A sphincterotome adapted to be advanced through the lumen of an endoscope and out an endoscope exit port into a sphincter opening of a sphincter in a patient's body to make a cut in alignment with a feature of the sphincter to enlarge the sphincter opening while avoiding endangering the patient, of the type comprising:

• an elongated sphincterotome body extending between a proximal end and a distal end formed of an elongated generally tubular, flexible tubular member having a proximal end segment extending distally from said proximal end and a distal end segment extending distally from a junction with said proximal end segment to said distal end, said flexible tubular member with a side wall dimensioned to fit within and be constrained by the endoscope lumen during advancement through the endoscope lumen, the flexible tubular member having an elongated axis extending between said proximal end and said distal end, and a flexible tubular member length sufficient to allow the flexible tubular member to be extended through said endoscope lumen to project at least said distal end segment thereof from said endoscope exit port and into proximity with the sphincter to be cut, said distal end segment being normally substantially straight and having a bending flexibility allowing a bend to be formed therein, said flexible tubular member containing a cutting wire lumen extending from said proximal end through said proximal end segment to a side wall exit port through said side wall at the junction of the proximal end segment with the distal end segment and first and second pull wire lumens extending through said flexible member length between a distal pull wire attachment point in said flexible tubular member proximal to said distal end and said proximal end of said sphincterotome body, said pull wire lumens being oriented within an arc of less than 180.degree. with respect to said longitudinal axis;
• a sphincterotome cutting wire having a proximal cutting wire end, a proximal cutting wire portion extending through said cutting wire lumen, an exposed cutting wire portion exiting through said side wall exit port and extending alongside said side wall of said distal end segment, and a distal cutting wire attached to said distal end segment adjacent said distal end of said sphincterotome body;
• first and second pull wires, extending within said first and second pull wire lumens, respectively, between said distal attachment point and said proximal end of said sphincterotome body;
• and
• a handle assembly at the proximal end of said sphincterotome body further comprising:
• cutting wire tensioning means coupled with said proximal cutting wire end and manipulatable to a slack position allowing said proximal cutting wire portion to be substantially slack within said cutting wire lumen and said exposed cutting wire portion to lie substantially slack alongside the side wall of said distal end segment during introduction of said distal end segment and exposed cutting wire portion to a body site through said endoscope lumen for performing a sphincterotomy, and manipulatable, upon advancement of said distal end segment and exposed cutting wire portion from said endoscope exit port, within a range of operative positions for partially retracting said exposed cutting wire portion into said side wall port and cutting wire lumen and forming a bend in said distal end segment separating said exposed cutting wire portion from said side wall of said distal end segment in a cutting plane for performing a sphincterotomy, said cutting plane defined by the retracted, exposed cutting wire portion and the bent distal end segment;
• and
• first and second pull wire tensioning means operable upon advancement of said distal end segment and said exposed cutting wire portion from said endoscope exit port and retraction of said exposed cutting wire port to form said cutting plane for selectively retracting one of said first and said second pull wires, respectively, through said first and said second respective pull wire lumens, and thereby applying a first or a second laterally displaced tension along a first or a second side of said distal end segment, respectively, effecting angular deflection of said cutting plane formed by said distal end segment and exposed cutting wire portion with respect to said longitudinal axis restrained by said endoscope lumen through respective first and second angular ranges of between about 25.degree. to 40.degree. deflection from said longitudinal axis to orient said exposed cutting wire portion into a preferred planar angular alignment with a desired feature of the sphincter opening to facilitate cutting of the patient's sphincter.

A method of surgically making a cut in alignment with a feature of a patient's sphincter to enlarge the sphincter opening while avoiding endangering the patient, comprising the steps of:

• providing a sphincterotome comprising:
• an elongated sphincterotome body having a proximal end and a distal end and a longitudinal axis extending therebetween, said sphincterotome body having a proximal end segment extending distally from said proximal end and a distal end segment extending distally from a junction with said proximal end segment to said distal end, said sphincterotome body further having a side wall dimensioned to be received in an endoscope lumen and having a predetermined length sufficient to allow the elongated sphincterotome body to be extended through said endoscope lumen to project at least a distal end segment thereof from said endoscope exit port and into proximity with the sphincter to be cut;
• a cutting wire having an exposed cutting wire portion located alongside said distal end segment of said sphincterotome body;
• means for supplying energy to said cutting wire to effect cutting of the patient's sphincter;
• deflecting means selectively operable from said proximal end for deflecting said distal end segment and said exposed cutting wire portion extending from said endoscope exit port laterally with respect to said longitudinal axis;
• and
• cutting plane defining means for selectively forming said distal end segment and said exposed cutting wire portion extending from said endoscope exit port into a cutting plane to enable cutting of the patient's sphincter;
• positioning an endoscope having an endoscope lumen terminating in an endoscope exit port near the sphincter to allow viewing of the sphincter and sphincter opening;
• extending said sphincterotome body through said endoscope lumen to project at least said distal end segment of said sphincterotome body and said exposed cutting wire portion out of said endoscope exit port and adjacent the sphincter opening;
• advancing at least a portion of said distal end segment and exposed cutting wire portion projecting out of said sphincterotome exit port into said sphincter opening;
• operating said cutting plane defining means to form said cutting plane to allow said exposed cutting wire portion to cut said sphincter when energized;
• operating said deflecting means to deflect said cutting plane with respect to said longitudinal axis to effect a desired planar angular alignment of said cutting plane with respect to a feature of the sphincter opening to facilitate cutting of the patient's sphincter by a cut made in the deflected cutting plane;
• and
• energizing said exposed cutting wire portion to effect cutting of said sphincter.

A sphincterotome adapted to be advanced through an endoscope lumen and out an endoscope exit port for cutting a sphincter in a patient's body to enlarge the sphincter opening while avoiding endangering the patient, said sphincterotome comprising:

• an elongated sphincterotome body having a proximal end and a distal end and a longitudinal axis extending therebetween, said sphincterotome body having a proximal end segment extending distally from said proximal end and a distal end segment extending distally from a junction with said proximal end segment to said distal end, said sphincterotome body further having a side wall dimensioned to be received in an endoscope lumen and having a predetermined length sufficient to allow the elongated sphincterotome body to be extended through said endoscope lumen to project at least a distal end segment thereof from said endoscope exit port and into proximity with the sphincter to be cut said sphincterotome body containing a cutting wire lumen extending from said proximal end through said proximal end segment to a side wall exit port through said side wall at the junction of the proximal end segment with the distal end segment;
• a cutting wire extending through said cutting wire lumen of the elongated sphincterotome body from the proximal end thereof and through said cutting wire exit port and alongside a distal end segment of said sphincterotome body to an attachment to said distal end;
• cutting plane forming means coupled with the proximal end of the sphincterotome body adapted to be manipulated after the distal end segment of the sphincterotome body is extended through said endoscope lumen and out the endoscope exit port to retract said cutting wire and said exposed cutting wire portion through said cutting wire lumen and exit port and to thereby form a cutting plane as a bend is induced in the distal end segment by the retraction of the exposed cutting wire portion, the cutting plane extending away from and in axial alignment with a longitudinal axis of the proximal end segment of the sphincterotome body restrained in the endoscope lumen, said cutting plane defined by the retracted, exposed cutting wire portion and the bent distal end segment;
• and
• deflecting means coupled with the proximal end of the sphincterotome body and extending through the length of said proximal end segment of said sphincterotome body to an attachment point with said distal end segment in proximity with said cutting wire exit port for deflecting the cutting plane laterally with respect to the longitudinal axis of the sphincterotome body exiting the endoscope exit port to a deflected position of said cutting plane to orient said exposed cutting wire portion into a preferred planar angular alignment with said desired feature of the sphincter opening to facilitate cutting of the patient's sphincter.