Balloon technology

Abstract

An apparatus for folding a catheter balloon comprises a stationary base member; a rotatable drive hub which is moveable in relation to the stationary base member; and a pleating head aligned with respect to the stationary base member and to the rotatable drive hub. The pleating head includes at least three segments, each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length. Each segment has a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, and the proximal point being pivotally coupled by pins to the stationary base member and the distal point being pivotally coupled by pins to the rotatable hub member. The segments are arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a spiral-pleat dimension having at least three channels in communication with a central aperture. Also, the segment centerlines extend therefrom toward the segment distal ends and are oriented away from the central point. The segment distal ends move closer to the central point upon rotation of the rotatable hub member in a predetermined direction, whereby the balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub. A method of pleating and folding a catheter balloon is also disclosed.

1 - 123 . (canceled)  
     
     
         124 . A balloon for a balloon catheter comprising a balloon body with a plurality of curved wings.  
     
     
         125 . The balloon of  claim 124 , wherein the balloon catheter has a tubular catheter shaft of a predetermined length.  
     
     
         126 . The balloon of  claim 125 , wherein the balloon body is connected to the catheter shaft.  
     
     
         127 . The balloon of  claim 126 , wherein the catheter shaft has proximal and distal ends, a guidewire lumen and an inflation lumen.  
     
     
         128 . The balloon of  claim 127  is connected to the catheter shaft adjacent to the distal end of the catheter shaft.  
     
     
         129 . The balloon of  claim 128 , wherein the balloon has an interior in fluid communication with the inflation lumen.  
     
     
         130 . The balloon of  claim 129 , wherein each wing has a base region disposed adjacent to the catheter shaft and an outwardly disposed tip.  
     
     
         131 . The balloon of  claim 124 , wherein the balloon has at least three wings.  
     
     
         132 . The balloon of  claim 131 , wherein the balloon has between three and sixteen wings.  
     
     
         133 . The balloon of  claim 124 , wherein the balloon is formed of a polymeric material.  
     
     
         134 . The balloon of  claim 124 , wherein the balloon has a base region which is inclined.  
     
     
         135 . The balloon of  claim 134 , wherein the base region is disposed adjacent to a shaft of the catheter.  
     
     
         136 . The balloon of  claim 134 , wherein the incline is viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft.  
     
     
         137 . The balloon of  claim 136 , wherein the incline is with respect to an imaginary line at the wing base, the line being tangent to the catheter shaft.  
     
     
         138 . The balloon of  claim 124 , wherein the inflatable balloon is uninflated.  
     
     
         139 . The balloon of  claim 138 , wherein the balloon has an unfolded state and a folded state wherein the wings are folded around the catheter shaft, the curved configuration of the wings being measured in the unfolded state.  
     
     
         140 . The balloon of  claim 124 , wherein the balloon catheter has an expandable stent mounted on the exterior of the balloon.  
     
     
         141 . An inflatable deflated balloon for a balloon catheter having a tubular catheter shaft, comprising a balloon body connected to the catheter shaft, the balloon body having a plurality of curved wings, each wing having a base region which is inclined as viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft and with respect to an imaginary line at the wing base, the line being tangent to the catheter shaft, the balloon further having an unfolded state and a folded state wherein the wings are folded around the catheter shaft, the curved configuration of the wings being measured in the unfolded state.  
     
     
         142 . An inflatable deflated balloon for a balloon catheter having a tubular catheter shaft, comprising a polymeric balloon body connected to the catheter shaft, the balloon body having between three and sixteen curved wings, each wing having a base region disposed adjacent to the catheter body and an outwardly disposed, the base region being incliend as viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft and with respect to an imaginary line at the wing base, the line being tangent to the catheter shaft, the balloon further having an unfolded state and a folded state wherein the wings are folded around the catheter shaft, the curved configuration of the wings being measured in the unfolded state.  
     
     
         143 . A balloon for a balloon catheter comprising a balloon body with a plurality of curved pleated portions.  
     
     
         144 . An inflatable deflated balloon for a balloon catheter having a tubular catheter shaft, comprising a balloon body connected to the catheter shaft, the balloon body having a plurality of curved pleated, each pleated portion having a base region which is inclined as viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft and with respect to an imaginary line at the pleated portion base, the line being tangent to the catheter shaft, the balloon further having an unfolded state and a folded state wherein the pleated portions are folded around the catheter shaft, the curved configuration of the pleated portions being measured in the unfolded state.  
     
     
         145 . A balloon catheter, comprising: 
 (a) a tubular catheter shaft; and    (b) a balloon connected to the catheter shaft, the balloon body having a plurality of curved wings.    
     
     
         146 . The balloon of  claim 145 , wherein the catheter shaft has proximal and distal ends, a guidewire lumen and an inflation lumen.  
     
     
         147 . The balloon of  claim 146  is connected to the catheter shaft adjacent to the distal end of the catheter shaft.  
     
     
         148 . The balloon of  claim 147 , wherein the balloon has an interior in fluid communication with the inflation lumen.  
     
     
         149 . The balloon of  claim 145 , wherein each wing has a base region disposed adjacent to the catheter shaft and a tip disposed at a terminal end of the wing.  
     
     
         150 . The balloon of  claim 145 , wherein the balloon has at least three wings.  
     
     
         151 . The balloon of  claim 150 , wherein the balloon has between three and sixteen wings.  
     
     
         152 . The balloon of  claim 145 , wherein the balloon is formed of a polymeric material.  
     
     
         153 . The balloon of  claim 145 , wherein the balloon has a base region which is inclined.  
     
     
         154 . The balloon of  claim 153 , wherein the base region is disposed adjacent to the catheter shaft.  
     
     
         155 . The balloon of  claim 153 , wherein the incline is viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft.  
     
     
         156 . The balloon of  claim 155 , wherein the incline is viewed with respect to an imaginary line at the wing base, the line being tangent to the catheter shaft.  
     
     
         157 . The catheter of  claim 145 , wherein the inflatable balloon is uninflated.  
     
     
         158 . The balloon of  claim 145 , wherein the balloon has an unfolded state and a folded state wherein the wings are folded around the catheter shaft, the curved configuration of the wings being measured in the unfolded state.  
     
     
         159 . The balloon of  claim 145 , further comprising an expandable stent mounted on the exterior of the balloon.  
     
     
         160 . A balloon catheter, comprising: 
 (a) a tubular catheter shaft; and    (b) an inflatable deflated balloon connected to the catheter shaft, the balloon body having a plurality of curved wings, each wing having a base region which is inclined as viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft and with respect to an imaginary line at the wing base, the line being tangent to the catheter shaft, the balloon further having an unfolded state and a folded state wherein the wings are folded around the catheter shaft, the curved configuration of the wings being measured in the unfolded state.    
     
     
         161 . A balloon expandable stent delivery catheter, comprising: 
 (a) a tubular catheter shaft;    (b) an inflatable deflated polymeric balloon connected to the catheter shaft, the balloon body having between three and sixteen curved wings, each wing having a base region disposed adjacent to the catheter body and an outwardly disposed, the base region being inclined as viewed in a crossectional plane which is perpendicular to the longitudinal axis of the catheter shaft and with respect to an imaginary line at the wing base, the line being tangent to the catheter shaft, the balloon further having an unfolded state and a folded state wherein the wings are folded around the catheter shaft, the curved configuration of the wings being measured in the unfolded state; and    (c) an expandable stent mounted on the exterior of the balloon.