Twist-in spring-skirt-like sphincterotome

1. A medical system for gaining access into a bodily lumen or stricture, the system comprising:

an elongate catheter extending along a longitudinal axis from a proximal end to a distal end, the distal end having an outer diameter, and a lumen extending through the catheter; and

a coiled engagement member comprising an elongate shaft and a coil fixedly attached to a distal end of the elongate shaft, the elongate shaft being movably disposed within the lumen of the catheter, the coil being disposed near the distal end of the catheter,

wherein the elongate shaft has sufficient torsional rigidity to transmit rotational motion from a proximal end of the elongate shaft to the coil;

wherein the coil comprises a wire that curves outwardly and proximally from the distal end of the elongate shaft to form a plurality of loops circumferentially disposed about the distal end of the elongate shaft and forming a spiral shape around the elongate shaft, the plurality of loops being configured to engage an inner tissue surface of a bodily lumen or stricture;

wherein an end of the wire is attached to a proximal-most loop of the plurality of loops,

wherein a diameter of an opening defined by the proximal-most loop is wider than the outer diameter of the distal end of the elongate catheter, and

wherein the system comprises a first configuration in which the plurality of loops are disposed circumferentially about the distal end of the catheter, and a second configuration in which the plurality of loops are disposed distally of the distal end of the catheter.

2. The medical system according to claim 1 wherein, in the first configuration, the coil is disposed about the catheter with a proximal end of the coil being spaced proximally from the distal end of the catheter.

3. The medical system according to claim 1 wherein, in the second configuration, the coil is disposed distally of the catheter with a proximal end of the coil being spaced distally of the distal end of the catheter.

4. The medical system according to claim 1 wherein the coil comprises a variable radius along a length thereof.

5. The medical system according to claim 1 wherein the wire of the coil is curvilinear and extends between a first end and a second end, the curvilinear wire having an intermediate portion forming a first loop and a second loop, the first end being integrally connected to the distal end of the elongate shaft, and the second end being affixed to the intermediate portion of the curvilinear wire.

6. The medical system according to claim 5 wherein the first loop and the second loop are approximately equal in size.

7. The medical system according to claim 5 wherein the first loop is larger than the second loop.

8. The medical system according to claim 5 wherein the first loop is smaller than the second loop.

9. The medical system according to claim 1 wherein the elongate shaft comprises a distal shaft section and an intermediate shaft section, the intermediate shaft section having a lateral flexibility that is greater than that of the distal shaft section.

10. The medical system according to claim 1 wherein the coil is eccentrically disposed relative to an axis of the elongate shaft.

11. The medical system according to claim 1 wherein the coil is re-configurable to a collapsed configuration having an outer diameter sufficiently small to pass through the lumen of the catheter.

12. The medical system according to claim 1 wherein the elongate catheter comprises a plurality of lumens extending therethrough.

13. The medical system according to claim 1 wherein the elongate catheter comprises a sphincterotome having an electrosurgical cutting wire disposed near the distal end thereof.

14. A method for gaining access into a bodily lumen or stricture, the method comprising the steps of:

providing a system according to claim 1 , and advancing the system to a target bodily lumen;

engaging the coil of the coiled engagement member with an inner surface of the target bodily lumen;

rotating the coil so as to advance the coil in a screw-like manner into a passageway of the target bodily lumen and secure the coil there within; and

retracting the coil in a generally proximal direction so as to one of smooth the inner surface of the target bodily lumen and align the passageway of the target bodily lumen with the longitudinal axis of the catheter.

15. The method of claim 14 further comprising the step of advancing the elongate catheter into the passageway of the target bodily lumen.

16. The method of claim 14 further comprising the step of advancing an elongate shaft guide through the lumen of the elongate catheter and into the passageway of the target bodily lumen.

17. The method of claim 14 wherein the target bodily lumen comprises an ampullae, the inner surface comprises inter-mural mucosa, and the passageway comprises the sphincter of oddi.