Adjustably stiffenable convertible catheter assembly

Abstract

A stiffenable balloon catheter assembly capable of being converted from an “over-the-wire” mode with respect to a guidewire extending therethrough to a “rapid-exchange” mode with respect to a guidewire extending therethrough, and vice versa. The catheter has a plurality of lumens, one lumen however, having a side opening with an obstructable galp, the orientation of which, determines the utilization “mode” of the catheter assembly. Stiffening stylets may be adjustably locked into the lumens, depending upon the “mode”, to control the stiffness of the catheter assembly during its utilization within a patient.

1 . A catheter assembly for insertion within a body vessel, said catheter assembly capable of being converted between an “over-the-wire” mode and a “rapid-exchange-wire” mode through a common lumen in said catheter assembly, comprising: 
 an elongated extruded flexible shaft having a proximal end and a distal end, said shaft having a balloon arranged about said distal end and a connector arranged at said proximal end;    a first and a second lumen arranged within said shaft, said second lumen being in fluid communication with the interior of said balloon for the enablement of inflation and deflation thereof; and    a third lumen extending between said proximal and    distal ends of said shaft, said third lumen having means therewith to facilitate conversation of said catheter between an “over-the-wire” mode and a Vapid-exchange-wire” mode with a guidewire arrangeable through at least a portion of said third lumen.    
   
   
       2 . A catheter assembly for insertion within a vessel as recited in  claim 1 , wherein said first lumen has a closed distal end arranged within said shaft, said first lumen being arranged to receive a stiffening means therein.  
   
   
       3 . A catheter assembly for insertion within a vessel as recited in  claim 1 , wherein said means to facilitate conversion of said catheter form the “over-the-wire” mode to the rapid-exchange-wire)I mode in said third lumen comprises a side opening disposed through the wall of said shaft, opening into said lumen to permit a guidewire to pass therethrough.  
   
   
       4 . A catheter assembly for insertion within a vessel as recited in  claim 3 , wherein said side opening is disposed in said shaft at a location proximal to said balloon on said shaft.  
   
   
       5 . A catheter assembly for insertion within a vessel as recited in  claim 3 , wherein said side opening has a resilient flap extending thereacross, and within said lumen, to act as a valve to minimize fluid leakage with respect to said lumen when said catheter is in said “over-the-wire” mode.  
   
   
       6 . A catheter assembly for insertion within a vessel 
 as recited in  claim 2 , wherein said stiffening means within said first lumen comprises a metal stiffening mandrel.    
   
   
       7 . A catheter assembly for insertion within a vessel as recited in  claim 6 , wherein said stiffening mandrel is made from a metal wire selected from the group consisting of stainless steel or Nitinol.  
   
   
       8 . A catheter assembly for insertion within a vessel as recited in  claim 6 , wherein said stiffening mandrel has a distalmost end which is emplaced within said catheter shaft, said stiffening mandrel extending adjacent said side opening distal to 
 the position of said side opening in said catheter shaft, to minimize kinking within said shaft.    
   
   
       9 . A catheter assembly for insertion within a vessel as recited in  claim 8 , wherein said stiffening mandrel is axially displaceable in said first lumen so as to effect the rigidity of said catheter shaft therealong.  
   
   
       10 . A catheter assembly for insertion within a vessel as recited in  claim 9 , wherein said first lumen has a clocking means on its proximal end, to engage said stiffening mandrel and prevent axial displacement therewith.  
   
   
       11 . A dilatation catheter made from a shaft of extrudable flexible material having proximal and distal ends, 
 said catheter having an expandable elongated balloon disposed about its distal end;    a first lumen disposed in said shaft, extending from said proximal end of said shaft, and having a closed end near the distal end of said shaft;    a third lumen disposed in said shaft comprising a tubular wall, extending from said proximal end of said shaft, through said balloon, said lumen having a terminal distal end which is open distally of said balloon;    a stiffening means disposed within said first lumen;    an obstructed opening arranged through said wall of said third lumen to provide access for a guidewire through the said lumen distally therepast.    
   
   
       12 . A dilatation catheter as recited in  claim 11  wherein said obstructed opening comprises a flexible flap, integral with said wall, disposed across said opening to permit said lumen to receive a guidewire through its full length thereof.  
   
   
       13 . A dilatation catheter as recited in  claim 12 , wherein said opening is disposed through said lumen wall, at an acute angle with respect to the longitudinal axis of said shaft.  
   
   
       14 . A dilatation catheter as recited in  claim 11 , wherein said third lumen is adaptable to receive a stiffening stylet and a guidewire therein, simultaneously.  
   
   
       15 . A dilatation catheter as recited in  claim 11 , wherein said lumen is adaptable to receive a stiffening stylet and a guidewire therein, simultaneously.  
   
   
       16 . A dilatation catheter as recited in  claim 15 , wherein said first lumen has a mandrel locking means at its proximal end thereof, to permit selective adjustment and engagement of said stiffening mandrel therein.  
   
   
       17 . A dilatation catheter as recited in  claim 15 , wherein said closed end of said first lumen is disposed distally on said shaft, with respect to said obstructed opening, so that when said stiffening mandrel is fully emplaced therein, said mandrel provides stiffness and resistance to kinking of said shaft fully across said obstructed opening.  
   
   
       18 . A dilatation catheter from a shaft of extrudable flexible material having a distal and a proximal end, said having an elongated expandable balloon disposed about its distal end; 
 a first lumen disposed in said catheter shaft, open at said proximal end, sand closed at said distal end, proximal of    said balloon, said first lumen adapted to receive a stiffening mandrel therein;    a second lumen disposed in said catheter shaft, open at said proximal end, and having its distal end in fluid communication with said balloon; and    a third lumen disposed in said catheter shaft, said third lumen having a means for converting said dilatation catheter between an over-the-wire mode an da rapid-exchange-wire mode.    
   
   
       19 . A dilatation catheter as recited in  claim 18 , wherein said third lumen is adaptable to receive a stiffening stylet and a separate guidewire therein, simultaneously.  
   
   
       20 . A dilatation catheter as recited in  claim 19 , wherein said stiffening stylet and said separate guidewire are coaxial while both are in said third lumen.  
   
   
       21 . A dilatation catheter as recited in  claim 18 , wherein said means for converting said catheter from an over-thewire mode to a rapid-exchange mode comprises an acutely disposed opening arranged through the sidewall of said shaft, and in communication with said lumen.  
   
   
       22 . A dilatation catheter as recited in  claim 18 , wherein a plurality of orificci are arranged through the wall of said lumen, both proximally adjacent and distally adjacent said balloon at the distal end of said shaft.  
   
   
       23 . A dilatation catheter as recited in  claim 21 , wherein said acutely disposed opening has a flexible flap arranged thereover and within said lumen, to provide an obstruction therewithin, said flap acting as a valve means with respect to said opening.  
   
   
       24 . A dilatation catheter as recited in  claim 18 , wherein said means for converting said catheter between an “over-the-wire” mode and a “rapid-exchange” mode comprises an acutely disposed slit arranged through the sidewall of said catheter shaft, creating a flexible flap which is bendable to establish an opening in the wall for passage of a guidewire therethrough.  
   
   
       25 . A dilatation catheter as recited in  claim 18 , wherein said means for converting said catheter between an “overthe wire” mode and a Vapid exchange” mode comprises a longitudinal slot disposed through the sidewall of said catheter shaft, and into said third lumen, for passage of a guidewire therethrough when said slot is flexed.  
   
   
       26 . A method of performing coronary angioplasty dilatation for opening a constriction in an artery of a patient, comprising the steps of: 
 providing an elongated guidewire having distal and proximal ends and a dilatation catheter comprising a shaft having    a distal and a proximal end, with an elongated expandable balloon disposed about its distal end, a first lumen with a closed distal end arranged therein proximal to said balloon, a second lumen in said shaft open at its proximal end and in fluid communication at its distal end with said balloon, and a third lumen extending the length of said shaft and open at each end thereof, said third lumen having means for converting said catheter between an overthe wire mode and a rapid-exchange mode, said means for converting said catheter comprising an obstructed opening through the side wall of said lumen proximal of said balloon, said first lumen having a stiffening mandrel therein, the distal end of    which extends in said first lumen distal of said obstructed opening;    inserting said guidewire into the vessel system of a patient;    positioning said catheter over the proximal end of said guidewire so that said guide wire is in a sliding fit within said third lumen of said shaft;    advancing said guidewire proximally through said third lumen; and    bending said catheter shaft so to as lift said obstruction from said opening in the side of said third lumen to cause the proximal end of said guidewire to exit out the side of said third lumen and extend externally thereof to the proximal end of said catheter, while positioning said balloon within a vessel obstruction.    
   
   
       27 . A method of performing coronary angioplasty dilatation as recited in  claim 26 , including the step of: 
 perfusing body fluid into said third lumen through a plurality of orificii adjacent said balloon, subsequently perfusing body fluid out of said third lumen on the other end of said balloon.    
   
   
       28 . A method of performing coronary angioplasty dilatation as recited in  claim 27 , including the steps of: 
 withdrawing said catheter shaft from the patient sufficient to bring the proximal end of said guidewire into juxtaposed correspondence with the side opening in said third lumen;    straightening said catheter shaft at the location of said opening in said third lumen; and    advancing the proximal end of said guidewire through 
 the proximal balance of said third lumen while advancing said catheter shaft back into the vessel system of the patient.  
   
   
   
       29 . A balloon dilatation perfusion catheter, comprising: 
 a balloon defining a balloon cavity therein;    a multi-lumen tubular member having a proximal end and a distal end extending through the balloon cavity;    a plurality of side openings arranged in the multi-lumen tubular member located both distal and proximal of the balloon and in fluid communication with one another via a first lumen in the multi-lumen tubular member, the first lumen extending from the proximal end of the multi-lumen tubular member through the tubular member to an end hole distal of the balloon;    a guide wire outlet opening in the multi-lumen tubular member proximal of the balloon in communication with the first lumen; and    a second lumen in the multi-lumen tubular member extending from the proximal end of the multi-lumen tubular member to the balloon and in the fluid communication with the balloon cavity wherein the first lumen is provided for receiving a guide wire or a temporary strengthening wire therein and the second lumen is provided for receiving a pressure fluid for inflating the balloon.    
   
   
       30 . A balloon dilatation perfusion catheter of  claim 1  wherein the guide wire outlet opening has the form of a longitudinal slot.