System and method for predictable deployment of a medical device

Abstract

A medical device system for the delivery of energy to a region of a patient's anatomy is provided. An introducer tube defines a lumen therein and bears a first electrode. A second electrode is movable within the lumen between a retracted position and an extended position. In the retracted position, the second electrode is substantially disposed within the lumen. In the extended position, the second electrode extends at least partially beyond the distal end of the introducer tube. In one form, the introducer tube is configured to substantially hold the second electrode within the lumen in a predetermined orientation in the extended position, and the introducer tube prevents the second electrode from substantially rotating within the lumen of the introducer tube during movement into the extended position. In one form, the introducer tube is more flexible in a first plane than in a second plane. A method is also provided.

What is claimed is: 
     
         1 . A medical device system for the delivery of energy to a region of a patient's anatomy, the medical device system comprising:
 an introducer tube defining a lumen therein, the introducer tube being configured to be inserted into the patient's anatomy, the introducer tube being a first electrode; and   a second electrode being movable within the lumen of the introducer tube between a retracted position and an extended position, wherein in the retracted position, the second electrode is substantially disposed within the lumen, and wherein in the extended position, the second electrode extends at least partially beyond the distal end of the introducer tube, the first and second electrodes being configured to deliver an energy to a tissue, the introducer tube being configured to substantially hold the second electrode within the lumen in a predetermined orientation in the extended position, the introducer tube preventing the second electrode from substantially rotating within the lumen of the introducer tube during movement into the extended position.   
     
     
         2 . The medical device system of  claim 1 , the second electrode being a coil having a collapsed straightened configuration in the retracted position and an expanded helix configuration in the extended position. 
     
     
         3 . The medical device system of  claim 2 , the coil having a substantially flat cross-sectional shape. 
     
     
         4 . The medical device system of  claim 3 , the first electrode comprising a piercing tip disposed at the distal end of the first electrode, the piercing tip being configured to pierce through a tissue. 
     
     
         5 . The medical device system of  claim 4 , the coil being a first coil, the retracted position being a first retracted position, and the extended position being a first extended position, the medical device system further comprising a second coil disposed within the lumen of the introducer tube in a second retracted position, the second coil being movable within the introducer tube between the second retracted position and a second extended position, wherein in the second extended position, the second coil extends at least partially beyond the distal end of the introducer tube, the second coil having a collapsed straightened configuration in the second retracted position and a helix expanded configuration in the second extended position. 
     
     
         6 . The medical device system of  claim 4 , further comprising a bronchoscope having a curved section disposed at a bronchoscope distal end, the bronchoscope defining a bronchoscope lumen therein, the introducer tube being at least partially disposed in the bronchoscope lumen and axially movable therein, the first electrode being more flexible in a first plane than in a second plane, the second plane being perpendicular to the first plane, wherein a bending orientation of the first electrode aligns with a bend in the curved section of the bronchoscope. 
     
     
         7 . The medical device system of  claim 4 , the coil having an outer perimeter, a height, and a width in the collapsed straightened configuration, the height and the width being non-equal, the first electrode having a form-fitting inner perimeter defining the lumen, the form-fitting inner perimeter corresponding to the outer perimeter of the coil. 
     
     
         8 . The medical device system of  claim 7 , wherein the first electrode has a hollow, rectangular cross-section with first, second, third, and fourth sides, the first and third sides being longer than the second and fourth sides, the coil being prevented from substantially rotating within the lumen by at least one of the first, second, third, and fourth sides. 
     
     
         9 . The medical device system of  claim 2 , wherein the first electrode has a hollow, ovular cross-section. 
     
     
         10 . The medical device system of  claim 7 , the first electrode having an outer sheath and an inner sheath disposed in the outer sheath, the outer sheath having a round, circular cross-section, the inner sheath defining the lumen. 
     
     
         11 . A medical device system for the delivery of energy to a region of a patient's anatomy, the medical device system comprising:
 an introducer tube defining an introducer tube lumen therein, the introducer tube being configured to be inserted into the patient's anatomy, the introducer tube being a first electrode;   a second electrode being movable within the introducer tube lumen between a retracted position and an extended position, wherein in the retracted position, the second electrode is substantially disposed within the introducer tube lumen, and wherein in the extended position, the second electrode extends at least partially beyond the distal end of the introducer tube, the first and second electrodes being configured to deliver an energy to a tissue, the introducer tube being more flexible in a first plane than in a second plane, wherein the first plane is perpendicular to the second plane.   
     
     
         12 . The medical device system of  claim 11 , wherein the second electrode is more flexible in the first plane than in the second plane. 
     
     
         13 . The medical device system of  claim 12 , the first electrode having an outer side having an open channel defined therein, the open channel extending at least partially along a length of the introducer tube. 
     
     
         14 . The medical device system of  claim 13 , the second electrode being a coil having a collapsed straightened configuration in the retracted position and an expanded helix configuration in the extended position, the coil having a substantially flat cross-sectional shape, the first electrode comprising a piercing tip disposed at the distal end of the introducer tube, the piercing tip being configured to pierce through a tissue, the medical device system further comprising an endoscope having a curved section disposed at an endoscope distal end, the endoscope defining an endoscope lumen therein, the introducer tube being at least partially disposed in the endoscope lumen and axially movable therein. 
     
     
         15 . The medical device system of  claim 14 , the introducer tube being configured to substantially hold the second electrode within the introducer tube lumen in a predetermined orientation in the extended position, the introducer tube preventing the second electrode from substantially rotating within the introducer tube lumen during movement into the extended position. 
     
     
         16 . A method of delivering energy to a patient's anatomy, the method comprising:
 piercing a hollow needle into a tissue in the patient's anatomy, the hollow needle being a first electrode, the hollow needle defining a needle lumen therein having an opening at a distal end;   extending a second electrode from the distal end of the hollow needle a first time;   activating the first electrode and a second electrode to deliver a first energy to the tissue through the first electrode and the second electrode;   retracting the second electrode into the needle lumen;   rotating the hollow needle by a predetermined number of degrees about a central axis of the distal end of the hollow needle, thus causing the second electrode within the needle lumen to also rotate by substantially the same predetermined number of degrees about the central axis;   extending the second electrode from the distal end of the hollow needle a second time; and   activating the first and second electrodes to deliver a second energy to the tissue through the first and second electrodes.   
     
     
         17 . The method of  claim 16 , further comprising substantially preventing the second electrode from rotating with respect to the hollow needle when the second electrode is retracted within or extended from the needle lumen. 
     
     
         18 . The method of  claim 17 , further comprising inserting the hollow needle through an endoscope, the step of rotating the hollow needle by a predetermined number of degrees about a central axis of the distal end of the hollow needle including rotating the endoscope by the predetermined number of degrees about the central axis, thus causing the hollow needle to also rotate by substantially the same predetermined number of degrees about the central axis.