Angioplasty Balloon With Concealed Wires

Abstract

A balloon catheter having wires situated between an outer layer and a surface of a balloon is described. Each wire may be confined within an interior space of a pocket or encapsulated within a sheath. The pocket includes the outer layer and the balloon surface. The outer layer and balloon surface are unattached to allow the wire to slidably fit between therewithin. The pocket is selectively bonded to the balloon. The sheath includes a preformed shape that completely circumscribes the wire along the longitudinal and radial directions of the wire. The confined and encapsulated feature of the wires enable the wires to be atraumatic and remain spaced apart during treatment of calcification of a lesion.

1 . A balloon catheter for dilation of a body lumen, comprising:
 a shaft having a distal end and a proximal end;   a balloon mounted on the distal end of the shaft, the balloon having a distal portion and a proximal portion, the shaft having an inflation lumen extending therethrough in fluid communication with an interior region of the balloon, the balloon thereby being expandable between a deflated state and an inflated state; and   a wire extending along an outer surface of the balloon, the wire disposed between the outer surface of the balloon and an outer layer, the outer layer at least partially circumscribing the wire along a longitudinal length of the wire, the outer layer having an axial length, the outer layer being attached to the outer surface of the balloon at one or more locations.   
   
   
       2 . The balloon catheter of  claim 1 , wherein the outer layer is unattached to the outer surface of the balloon at one or more regions, thereby forming a pocket between the outer layer and the outer surface of the balloon, and the wire being disposed within the pocket. 
   
   
       3 . The balloon catheter of  claim 2 , wherein the pocket is longitudinally aligned with a longitudinal axis of the balloon, the pocket comprising a first opening adapted to slidably receive a wire. 
   
   
       4 . The balloon catheter of  claim 3 , the pocket further comprising a seam to define the edges of the pocket. 
   
   
       5 . The balloon catheter of  claim 2 , wherein a retaining element is affixed to the wire to maintain the wire in the pocket. 
   
   
       6 . The balloon catheter of  claim 3 , wherein the first opening is sealed to enclose the wire within the pocket. 
   
   
       7 . The balloon catheter of  claim 2 , wherein the wire is not bonded to interior surfaces of the pocket. 
   
   
       8 . The balloon catheter of  claim 1 , wherein the outer layer is a sheath encapsulating the wire, the sheath completely circumscribing the wire along a longitudinal length of the wire. 
   
   
       9 . A balloon catheter for dilation of a body lumen, comprising:
 a shaft having a distal end and a proximal end;   a balloon mounted on the distal end of the shaft, the shaft having an inflation lumen extending therethrough in fluid communication with an interior region of the balloon, the balloon thereby being expandable between a deflated state and an inflated state, wherein at least a length of an outer surface of the balloon comprises a working diameter adapted to dilate the body lumen, the length extending between a balloon proximal end and a balloon distal end;   a pocket disposed along at least a portion of the outer surface of the balloon, the pocket comprising an interior space defined by portions of an outer layer selectively unattached to the outer surface, the pocket further comprising a seam defined by portions of the outer layer attached to the outer surface of the balloon, the outer layer disposed over the outer surface of the balloon and extending along a portion of the working diameter of the balloon;   a wire disposed within the interior space defined by the pocket; and   a retaining element affixed to the wire, the retaining element preventing the wire from sliding out of the pocket.   
   
   
       10 . The balloon catheter of  claim 9 , wherein the seam comprises an undulating shape. 
   
   
       11 . The balloon catheter of  claim 9 , wherein the attachment of the outer layer to the outer surface of the balloon at the one or more locations comprises heat bonding, solvent bonding, or adhesive bonding the outer layer to the outer surface. 
   
   
       12 . The balloon catheter of  claim 9 , wherein the catheter comprises a plurality of pockets. 
   
   
       13 . The balloon catheter of  claim 12 , wherein the plurality of pockets are longitudinally aligned with a longitudinal axis of the balloon, the plurality of pockets being circumferentially equidistant from each other. 
   
   
       14 . A balloon catheter for dilation of a body lumen, comprising:
 a shaft having a distal end and a proximal end;   a balloon mounted on the distal end of the shaft, the shaft having an inflation lumen extending therethrough in fluid communication with an interior region of the balloon, the balloon thereby being expandable between a deflated state and an inflated state, wherein at least a length of an outer surface of the balloon comprises a working diameter adapted to dilate the body lumen, the length extending between a balloon proximal end and a balloon distal end; and   a wire comprising an axial length, the wire encapsulated by a sheath disposed along a portion of the working diameter of the balloon, the sheath being disposed over an outer surface of the balloon.   
   
   
       15 . The balloon catheter of  claim 14 , wherein the sheath has a tubular shape, the sheath fusion bonded to the outer surface of the balloon. 
   
   
       16 . The balloon catheter of  claim 14 , the sheath being movable between a first position and a second position, wherein the first position comprises a resting state where the balloon is deflated and the second position comprises a stretched state where the balloon is inflated. 
   
   
       17 . The balloon catheter of  claim 14 , wherein the wire comprises a non-adhesive coating to minimize bonding with the sheath. 
   
   
       18 . The balloon catheter of  claim 14 , wherein the sheath comprises a cutting edge. 
   
   
       19 . The balloon catheter of  claim 14 , wherein the wire has a proximal end and a distal end, the sheath axially extending past the proximal and the distal ends. 
   
   
       20 . The balloon catheter of  claim 14 , wherein the sheath circumscribes the wire along the entire axial length of the wire.