Stiffened balloon apparatus

Abstract

A stiffened balloon apparatus for use in angioplasty. Elongate stiffening members disposed longitudinally on the expandable balloon stiffen the membrane of said balloon. The stiffening members possess sufficient rigidity to resist local deformation of the wall of said expandable balloon upon expansion of said balloon and upon contact of said stiffening member with a local deformation within an anatomical passage or target lumen. Projections and/or raised surfaces on a stiffening member may engage, incise, crush, fracture, or pierce occlusions and/or the inner surface of the passage or target lumen in which it is being operated. Associated method for use to incise the inner surface of a target lumen or incise the stenosis that may be located therein.

1 - 47 . (canceled) 
     
     
         48 . A stiffened balloon apparatus for use within an anatomical passage in the human body comprising:
 an expandable balloon having at least one elongate stiffening member disposed longitudinally along a perimeter of said balloon;   
       wherein said balloon is made of a flexible material; 
       wherein said stiffening member is stiffer than said balloon material such that said stiffening member will resist deformation of the balloon membrane of said balloon; and 
       wherein at least one of the one or more stiffening members includes a plurality of projections, said projections being outwardly disposed in an orientation substantially perpendicular to the balloon surface when said balloon is inflated. 
     
     
         49 . The Stiffened balloon apparatus of  claim 48  wherein the spacing between each of said projections are of equal length. 
     
     
         50 . The stiffened balloon apparatus of  claim 48  wherein each of said plurality of projections possesses an outermost edge oriented longitudinally. 
     
     
         51 . The stiffened balloon apparatus of  claim 48  wherein the outer surface of at least one of said projections is pointed. 
     
     
         52 . The stiffened balloon apparatus of  claim 48  wherein outermost contour of at least one of said projections is rounded. 
     
     
         53 . The Stiffened balloon apparatus of  claim 48  wherein said projections have an outward-most surface that is curvilinear in a plane perpendicular to said balloon surface. 
     
     
         54 . The stiffened balloon apparatus of  claim 48  wherein said plurality of projections have an outer edge surface that is curvilinear and oriented longitudinally. 
     
     
         55 . The stiffened balloon apparatus of  claim 48  wherein said plurality of projections form a cutting edge along the outermost surface of said stiffening member. 
     
     
         56 . The stiffened balloon apparatus of  claim 48  wherein each of said projections possesses a cutting edge oriented longitudinally with respect to the longitudinal axis of said balloon. 
     
     
         57 . The stiffened balloon apparatus of  claim 48  wherein said plurality of projections form an array of incising elements. 
     
     
         58 . The stiffened balloon apparatus of  claim 48  wherein said plurality of projections form a saw-tooth edge on the outer surface of said stiffening member. 
     
     
         59 . The stiffened balloon apparatus of  claim 48  wherein said plurality of projections form a serrated structure on the outer surface of said stiffening member. 
     
     
         60 . The stiffened balloon apparatus of  claim 48  wherein said plurality of projections form a serrated pattern to allow said stiffening member to incise an inner surface of an anatomical lumen. 
     
     
         61 . The stiffened balloon apparatus of  claim 48  further comprising a plurality of stiffening members;
 wherein each of said plurality of stiffening members comprises a plurality of projections that are uniformly spaced along the length of each of said stiffening members in a serrated pattern;
 wherein each of said projections has an outermost surface that is curvilinear and oriented longitudinally with respect to the longitudinal axis of said balloon. 
 
 
     
     
         62 . A stiffened balloon apparatus for use within an anatomical passage in the human body comprising:
 an expandable balloon having at least one elongate stiffening member disposed longitudinally along a perimeter of said balloon;   wherein said balloon is made of a flexible material;   wherein said stiffening member is stiffer than said balloon material such that said stiffening member will resist deformation of the balloon membrane of said balloon; and   wherein at least one of the one or more stiffening members includes a raised surface, said raised surface being outwardly disposed in an orientation substantially perpendicular to the balloon surface when said balloon is inflated.   
     
     
         63 . The stiffened balloon apparatus of  claim 62  wherein said raised surface comprises an edge on its outermost surface configured to incise the inside surface of a target lumen upon expansion of said stiffened balloon. 
     
     
         64 . The stiffened balloon apparatus of  claim 62  wherein said raised surfaces are sufficiently sharp to pierce an occlusion. 
     
     
         65 . The stiffened balloon apparatus of  claim 62  wherein at least one of said one or more stiffening members comprises a plurality of raised surfaces. 
     
     
         66 . The stiffened balloon apparatus of  claim 65  wherein each of said raised surfaces comprises a rounded edge on its outermost surface oriented longitudinally and configured to incise the inside surface of a target lumen upon expansion of said stiffened balloon. 
     
     
         67 . A method of incising the inner surface of a target lumen within an anatomical passage in the human body, comprising the steps of:
 (1) Introducing into an anatomical passage a stiffened balloon apparatus for use within an anatomical passage in the human body, said stiffened balloon apparatus comprising:   an expandable balloon having at least one elongate stiffening member disposed longitudinally along a perimeter of said balloon;   wherein said balloon is made of a flexible material;   wherein said stiffening member is stiffer than said balloon material such that said stiffening member will resist deformation of the balloon membrane of said balloon; and   wherein at least one of the one or more stiffening members includes a plurality of projections, said projections being outwardly disposed in an orientation substantially perpendicular to the balloon surface when said stiffened balloon is inflated;   (2) Navigating said stiffened balloon apparatus through said anatomical passage to enter said target lumen;   (3) Upon entering said target lumen, inflating said balloon so that it expands radially, such that said stiffening members contact said inner surface of said target lumen and such that said projections engage said inner surface of said target lumen to incise said inner surface of said target lumen.   
     
     
         68 . The method of  claim 67  further comprising the step of maneuvering said stiffened balloon apparatus to further incise said inner surface of said target lumen. 
     
     
         69 . The method of  claim 67  further comprising the steps of:
 (4) deflating said balloon; 
 (5) moving said stiffened balloon apparatus to a different target location; and 
 (6) re-inflating said balloon so that it expands radially, such that said stiffening members contact the inner surface of said different target location and such that said projections engage said inner surface of said different target location to incise said inner surface of said different target location.