Rapid Exchange Catheter with Stent Deployment, Therapeutic Infusion, and Lesion Sampling Features

Abstract

A catheter is insertable into a vessel within a mammalian body. The catheter includes a tubular body, at least one channel extending along the tubular body; and a central lumen. The tubular body includes an exterior surface, a first end and a second end, and defines a length between the first end and the second end. The channel passes between a first opening and a second opening and includes a slot in the tubular body between the channel and the exterior surface of the tubular body such that a tubular member can be passed between the channel and the exterior surface. The slot extends from the first opening to the second opening and includes a pair of edges. The central lumen extends along the tubular body at least for a portion of the length of the tubular body. The catheter can be used as a rapid exchange catheter, for stent deployment, for drug delivery or therapeutic infusion with or without electroporation, to provide localized heat, to provide ultrasonic visualization and ablation, and to examine for vulnerable plaque. The catheter may have multiple balloons.

1 .- 37 . (canceled)  
   
   
       38 . A catheter configured to be inserted into a vessel within a mammalian body, the catheter comprising: 
 a tubular body having an exterior surface, a first end and a second end that define a length between the first end and the second end, and a central lumen extending along the tubular body at least for a portion of the length of the tubular body; and    at least one channel extending along the exterior surface of the tubular body at least for a portion of the length of the tubular body, the channel including a first opening, a second opening, and the channel passing between the first opening and the second opening, wherein the channel includes a slot opening into the channel such that a tubular member can be passed between the channel and the exterior surface of the tubular body, wherein the slot extends from the first opening to the second opening and includes a pair of edges,    wherein the tubular body has a circumference that defines a non-circular shape.    
   
   
       39 . The catheter of  claim 38 , further comprising a balloon extending around the tubular body proximal of the second end of the tubular body.  
   
   
       40 . The catheter of  claim 39 , wherein at least a portion of the balloon is in contact with the exterior surface of the tubular body and the channel.  
   
   
       41 . The catheter of  claim 39 , wherein the balloon extends into the channel for at least a portion of the length of the channel.  
   
   
       42 . The catheter of  claim 41 , wherein the balloon further includes a first surface extending from the channel and a second surface extending from the channel.  
   
   
       43 . The catheter of  claim 42 , wherein each of the first surface and the second surface include a radially extending channel passing between the channel and an opening on an outer surface of the balloon.  
   
   
       44 . The catheter of  claim 40 , further comprising a band encircling at least a portion of a circumference of the tubular body under the balloon.  
   
   
       45 . The catheter of  claim 39 , wherein the balloon comprises at least two discrete diameters.  
   
   
       46 . The catheter of  claim 39 , wherein the balloon comprises a diameter that is tapered along a length of the balloon.  
   
   
       47 . The catheter of  claim 39 , wherein the balloon is a stent delivery balloon.  
   
   
       48 . The catheter of  claim 38 , wherein the edges of the slot overlap.  
   
   
       49 . The catheter of  claim 38 , wherein the edges of the slot are aligned and in contact along at least a portion of the length of the edges without being connected.  
   
   
       50 . The catheter of  claim 38 , wherein the edges are aligned and spaced apart from one another.  
   
   
       51 . The catheter of  claim 38 , wherein the non-circular shape comprises a generally oval shape.  
   
   
       52 . The catheter of  claim 38 , wherein the non-circular shape comprises a height that is greater than a width.  
   
   
       53 . The catheter of  claim 38 , wherein the tubular body and channel are integrally formed.  
   
   
       54 . The catheter of  claim 53 , wherein the slot opening into the channel is formed in a secondary operation.  
   
   
       55 . The catheter of  claim 53 , wherein integrally forming the tubular body and the channel comprises extruding the tubular body and channel together.  
   
   
       56 . The catheter of  claim 38 , wherein at least a portion of the central lumen of the tubular body and the channel run parallel to each other within an oval-shaped segment of the catheter.  
   
   
       57 . The catheter of  claim 38 , further comprising a second channel extending longitudinally along the tubular body at least for a portion of the length of the tubular body.  
   
   
       58 . The catheter of  claim 38 , wherein the catheter is intended to be used to carry a guide wire or pacemaker lead in the channel.  
   
   
       59 . The catheter of  claim 38 , wherein the tubular member comprises a guide wire or pacemaker lead.  
   
   
       60 . A catheter and guide wire exchange system comprising a catheter configured to be inserted into a vessel within a mammalian body, the catheter comprising: 
 a tubular body having an exterior surface, a first end and a second end that define a length between the first end and the second end, a central lumen extending along the tubular body at least for a portion of the length of the tubular body, and a stiffening member positioned within at least a portion of the length of the tubular body; and    at least one channel extending along the exterior surface of the tubular body at least for a portion of the length of the tubular body, the channel including a first opening, a second opening, and the channel passing between the first opening and the second opening, wherein the channel includes a slot opening into the channel such that a tubular member can be passed between the channel and the exterior surface of the tubular body, wherein the slot extends from the first opening to the second opening and includes a pair of edges,    wherein the tubular body has a circumference that defines a non-circular shape.    
   
   
       61 . The catheter and guide wire exchange system of  claim 60 , wherein the stiffening member is one or more of a metal wire, a metal tube, a metal alloy tube, a coil, polyimide tube, or polyimide tube with a coil.  
   
   
       62 . The catheter and guide wire exchange system of  claim 61 , wherein the catheter shaft has been formed by continually extruding thermoplastic over one or more of the metal tubing, metal wire, coil, metal alloy tube, a coil, polyimide tube, or polyimide tube with a coil, then cutting the extrudate into individual catheter lengths.  
   
   
       63 . The catheter and guide wire exchange system of  claim 61 , wherein the catheter shaft has been formed by extruding thermoplastic over discrete lengths of one or more of the metal tubing, metal wire, metal alloy tube, coil, polyimide tube, or a polyimide tube with a coil.  
   
   
       64 . The catheter and guide wire exchange system of  claim 60 , further comprising a balloon extending around the channel and the tubular body proximal of the second end of the tubular body.  
   
   
       65 . The catheter and guide wire exchange system of  claim 64 , wherein the balloon is a stent delivery balloon.