Apparatus and methods for treating obstructions within body lumens

Abstract

An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

1 . An apparatus for treating a body lumen, comprising:
 an elongate tubular member including a proximal end, a distal end sized for introduction into a body lumen, and a first lumen extending between the proximal and distal ends;   an expandable balloon comprising a proximal end secured to the tubular member distal end, and a distal end comprising an outlet, the balloon comprising an interior communicating with the first lumen and the balloon outlet;   an elongate member slidably disposed within the first lumen, the elongate member comprising a proximal end adjacent the tubular member proximal end, and a distal end extending from the balloon outlet; and   a sealing member on the elongate member distal end, the elongate member being movable between a first position wherein the sealing member is spaced from the balloon outlet such that fluid introduced through the first lumen passes through the balloon interior and out the balloon outlet, and a second position wherein the sealing member substantially seals the balloon outlet such that fluid introduced through the first lumen enters the balloon interior to expand the balloon.   
     
     
         2 . The apparatus of  claim 1 , wherein the sealing member has a cross-section larger than the balloon outlet. 
     
     
         3 . The apparatus of  claim 2 , wherein the elongate member distal end has a cross-section smaller than the balloon outlet such that an annular lumen is defined between the elongate member and the balloon outlet for delivering fluid from the balloon interior through the balloon outlet when the elongate member is in the first position. 
     
     
         4 . The apparatus of  claim 1 , wherein the elongate member has a cross-section smaller than the first lumen such that an annular lumen is defined between the elongate member and the tubular member for delivering fluid from the tubular member proximal end into the balloon interior. 
     
     
         5 . The apparatus of  claim 1 , wherein the balloon comprises elastic material. 
     
     
         6 . The apparatus of  claim 1 , wherein the balloon comprises substantially inelastic material. 
     
     
         7 . The apparatus of  claim 1 , further comprising a handle on the tubular member proximal end, and an actuator on the handle for directing the elongate member between the first and second positions. 
     
     
         8 . The apparatus of  claim 1 , wherein the elongate member is biased to one of the first and second positions. 
     
     
         9 . The apparatus of  claim 1 , further comprising a helical member including a first end coupled to the tubular member distal end and a second end coupled to the elongate member distal end, the helical member extending helically around the elongate member within the balloon interior, the elongate member movable to a third position in which the elongate member distal end is directed towards the tubular member distal end to cause the helical member to expand radially outwardly to an expanded helical shape, thereby expanding the balloon to the expanded helical shape. 
     
     
         10 . The apparatus of  claim 9 , wherein the helical member second end is coupled to a stop secured to the elongate member distal end, the stop having a cross-section larger than the balloon outlet such that the stop limits relative movement of the balloon distal end relative to the elongate member distal end as the elongate member is directed between the second and third positions. 
     
     
         11 . The apparatus of  claim 9 , further comprising a source of vacuum communicating with the first lumen for collapsing the balloon before the elongate member is directed to the third position such that the balloon conforms substantially to the expanded helical shape of the helical member. 
     
     
         12 . The apparatus of  claim 9 , wherein the balloon distal end is directed towards the balloon proximal end when the elongate member is moved to the third position, thereby axially compressing the balloon. 
     
     
         13 . The apparatus of  claim 12 , further comprising a stop on the elongate member distal end proximal to the balloon distal end, the elongate member movable from the third position back towards the second position, thereby extending and collapsing the helical member, the stop engaging the balloon distal end and directing the balloon distal end distally as the elongate member is moved from the third position back towards the second position, thereby axially extending and collapsing the balloon. 
     
     
         14 . An apparatus for treating a body lumen, comprising:
 an outer tubular member including a proximal end, a distal end sized for introduction into a body lumen, and a first lumen extending between the proximal and distal ends;   an expandable balloon comprising a proximal end secured to the outer member distal end, and a distal end comprising an outlet, the balloon comprising an interior communicating with the first lumen and the balloon outlet;   an inner member slidably disposed within the first lumen and having a cross-section smaller than the first lumen such that an annular lumen is defined between the outer and inner members between the proximal and distal ends of the outer member, the inner member comprising a proximal end adjacent the outer member proximal end, and a distal end extending from the balloon outlet;   a sealing member on the inner member distal end, the inner member movable between a first position wherein the sealing member is spaced from the balloon outlet such that fluid introduced through the first lumen passes through the balloon interior and out the balloon outlet, and a second position wherein the sealing member substantially seals the balloon outlet such that fluid introduced through the first lumen enters the balloon interior to expand the balloon; and   a helical member comprising a first end coupled to the outer member distal end and a second end coupled to the inner member distal end, the helical member extending helically around the inner member within the balloon interior, the inner member movable to a third position in which the inner member distal end is directed towards the outer member distal end to cause the helical member to expand radially outwardly, thereby expanding the balloon to an expanded helical shape.   
     
     
         15 . The apparatus of  claim 14 , wherein the balloon comprises substantially inelastic material. 
     
     
         16 . The apparatus of  claim 14 , wherein the helical member second end is coupled to a stop secured to the inner member distal end, the stop having a cross-section larger than the balloon outlet such that the stop limits relative movement of the balloon distal end relative to the inner member distal end as the elongate member is directed between the second and third positions. 
     
     
         17 . The apparatus of  claim 14 , further comprising a source of vacuum communicating with the first lumen for collapsing the balloon before the inner member is directed to the third position such that the balloon conforms substantially to the shape of the helical member as the balloon is expanded to the expanded helical shape. 
     
     
         18 . An apparatus for treating a body lumen, comprising:
 an outer tubular member including a proximal end, a distal end sized for introduction into a body lumen, and a first lumen extending between the proximal and distal ends;   an inner member slidably disposed within the first lumen and having a cross-section smaller than the first lumen such that an annular lumen is defined between the outer and inner members between the proximal and distal ends of the outer member, the inner member comprising a proximal end adjacent the outer member proximal end, and a distal end extending beyond the outer member distal end;   an expandable balloon comprising a proximal end secured to the outer member distal end, and a distal end coupled to the inner member distal end, the balloon comprising an interior communicating with the first lumen and the balloon outlet;   a source of inflation media communicating with the first lumen for delivering inflation media through the first lumen into the balloon interior for expanding the balloon radially outwardly from a contracted condition to a cylindrical expanded condition; and   a helical member comprising a first end coupled to the outer member distal end and a second end coupled to the inner member distal end, the helical member extending helically around the inner member within the balloon interior, the inner member movable from a first distal position in which the helical member is disposed adjacent the inner member and the balloon is in the contracted condition to a second proximal position that causes the helical member to compress axially and expand radially outwardly, thereby compressing axially and expanding radially the balloon to an expanded helical shape.   
     
     
         19 . The apparatus of  claim 18 , wherein the helical member comprises first and second regions between the first and second ends, the first region expandable to a diameter greater than the second region such that the balloon defines first and second helical regions in the expanded helical shape, the first helical region having a diameter greater than the second helical region. 
     
     
         20 . The apparatus of  claim 18 , further comprising a source of vacuum communicating with the first lumen for collapsing the balloon towards the contracted condition before the inner member is directed to the second position such that the balloon conforms substantially to the shape of the helical member in the expanded helical shape. 
     
     
         21 . An apparatus for treating a body lumen, comprising:
 an outer tubular member including a proximal end, a distal end sized for introduction into a body lumen, and a first lumen extending between the proximal and distal ends;   an inner member slidably disposed within the first lumen and comprising a proximal end adjacent the outer member proximal end, and a distal end extending beyond the outer member distal end;   an expandable balloon comprising a proximal end secured to the outer member distal end, and a distal end coupled to the inner member distal end, the balloon comprising an interior communicating with the first lumen and the balloon outlet; and   a helical member comprising a first end coupled to the outer member distal end and a second end coupled to the inner member distal end, the helical member extending helically around the inner member within the balloon interior, the inner member movable from a first distal position in which the helical member is disposed adjacent the inner member and the balloon is in the contracted condition to a second proximal position that causes the helical member to compress axially and expand radially outwardly, thereby compressing axially and expanding radially the balloon to an expanded helical shape, the helical member comprising first and second regions between the first and second ends, the first region expandable to a diameter greater than the second region such that the balloon defines first and second helical regions in the expanded helical shape, the first helical region having a diameter greater than the second helical region.