Guidewire replacement device

Abstract

A guidewire replacement device having an elongated catheter shaft with an inner lumen extending within the catheter shaft, a proximal guidewire port spaced at least 1 cm from the distal end of the catheter which is in fluid communication with the inner lumen and a distal guidewire port in the distal end of the catheter which is also in fluid communication with the inner lumen. The proximal end of an in-place guidewire is inserted through the distal guidewire port and advanced through the inner lumen until the proximal end of the guidewire extends through the proximal guidewire port. The exchange device is advanced over the guidewire until the distal end of the exchange device is seated within the proximal guidewire port in the readily exchangeable dilatation catheter. With the distal end of the exchange device well seated within the proximal guidewire port of the dilatation catheter, the in-place guidewire can be withdrawn from the patient. A replacement guidewire is advanced through the inner lumen of the exchange device until it exits the distal guidewire port of the exchange device into the inner guidewire receiving lumen of the dilatation catheter. Once the replacement guidewire is properly placed, the exchange device can then be withdrawn from the patient.

What is claimed:  
     
         1 . A guidewire exchange device comprising, an elongated shaft having proximal and distal ends, and a guidewire receiving inner lumen extending therein at least from a proximal guidewire port to a distal guidewire port in the distal end thereof, the distal end of the shaft being adapted to be inserted into a guidewire port in a rapid exchange type dilatation catheter.  
     
     
         2 . The guidewire exchange device of  claim 1  wherein the proximal guidewire port in the catheter shaft is spaced proximally at least about 1 cm from the distal guidewire port of the catheter shaft.  
     
     
         3 . The guidewire exchange device of  claim 1  wherein a guidewire passageway extends between the proximal guidewire port and the guidewire receiving inner lumen extending within the distal section of the exchange device.  
     
     
         4 . The guidewire exchange device of  claim 3  wherein the guidewire passageway is in-line with the guidewire receiving inner lumen which extends within the distal section of the exchange device.  
     
     
         5 . The guidewire exchange device of  claim 1  wherein the most distal portion of the catheter shaft is adapted to be inserted through the proximal guidewire port of a rapid exchange type dilatation catheter having perfusion ports between the proximal guidewire port and the inflatable member thereof and be advanced within a guidewire receiving inner lumen which extends between the proximal guidewire port and the distal guidewire port in the dilatation catheter.  
     
     
         6 . A balloon dilatation catheter kit comprising: 
 a) a balloon dilatation catheter having an elongated shaft with an inflatable balloon on the distal portion thereof and a guidewire-receiving inner lumen which extends from a distal guidewire port in the distal end of the dilatation catheter to a proximal guidewire port spaced proximally from the distal guidewire port and a substantial distance distally from the proximal end of the elongated shaft; and    b) a guidewire exchange device having an elongated shaft with an inner lumen extending therein, a distal guidewire port in the distal end of the exchange device and a proximal guidewire port spaced at least 1 cm from the distal end of the exchange device, the distal end of the guidewire exchange device being shaped and dimensioned to enter the proximal guidewire port of the dilatation catheter.    
     
     
         7 . The kit of  claim 6  wherein perfusion ports are provided in the elongated shaft of the balloon dilatation catheter proximal and distal to the balloon in communication with the guidewire-receiving inner lumen.  
     
     
         8 . The kit of  claim 7  wherein the distal portion of the guidewire exchange device is dimensioned to slide over a guidewire disposed within the guidewire-receiving inner lumen, through the proximal guidewire port and into the guidewire-receiving inner lumen.  
     
     
         9 . The kit of  claim 6  including a guidewire having an elongated core and a flexible body on the distal portion thereof and adapted to be disposed at least partially within the guidewire receiving inner lumen of the dilatation catheter.  
     
     
         10 . A method for exchanging a guidewire during an angioplasty procedure wherein a readily exchangeable dilatation catheter having a short guidewire receiving inner lumen in the distal portion thereof extending between a distal guidewire port in the distal end of the dilatation catheter and a proximal guidewire port spaced at least 10 cm from the distal guidewire port, is disposed within a patient's vasculature and wherein a first guidewire having proximal and distal ends extends through the short guidewire receiving inner lumen within the distal portion of dilatation catheter, the method comprising: 
 a) providing a guidewire exchange device comprising an elongated shaft with a guidewire receiving inner lumen extending therein, a distal guidewire port in the distal end of the exchange device and a proximal guidewire port spaced at least 10 cm from the distal end of the exchange device, both of said guidewire ports being in fluid communication with the inner lumen of the exchange device, and the distal end of the guidewire exchange device being adapted to enter the proximal guidewire port of the dilatation catheter;    b) mounting the guidewire exchange device onto the proximal end of the first guidewire;    c) advancing the guidewire exchange device over the first guidewire until the distal end of the exchange device enters into the proximal guidewire port of the dilatation catheter;    d) withdrawing the first guidewire through the guidewire exchange device by pulling the first guidewire from its proximal end; and    f) advancing a second guidewire through the inner lumen of the guidewire exchange device, through the short guidewire receiving inner lumen in distal extremity of the dilatation catheter and out the distal end thereof.    
     
     
         11 . A balloon dilatation catheter assembly comprising: 
 a) a balloon dilatation catheter having an elongated shaft with an inflatable balloon on the distal portion thereof and a guidewire-receiving inner lumen which extends between a distal guidewire port in the distal end of the dilatation catheter and a proximal guidewire port spaced at least 10 cm from the distal guidewire port;    b) an guidewire having an elongated core and a flexible body on the distal portion thereof and being disposed at least partially within the guidewire receiving inner lumen of the dilatation catheter; and    c) a guidewire exchange device having an elongated shaft with an inner lumen extending therein, a distal guidewire port in the distal end of the exchange device and a proximal guidewire port spaced at least 10 cm from the distal end of the exchange device, the distal end of the guidewire exchange device being dimensioned to be seated within the proximal guidewire port of the dilatation catheter.    
     
     
         12 . The assembly of  claim 11  wherein the elongated shaft of the balloon dilatation catheter has perfusion ports which are located proximal and distal to the balloon and which are in fluid communication with the guidewire-receiving inner lumen.  
     
     
         13 . The assembly of  claim 12  wherein the guidewire exchange device is dimensioned to slide over a guidewire disposed within the guidewire-receiving inner lumen, through the proximal guidewire port and the guidewire-receiving inner lumen.  
     
     
         14 . A method for exchanging a guidewire disposed within a short guidewire receiving inner lumen in the distal portion of an intravascular catheter which is placed within a patient during an intravascular procedure comprising: 
 a) providing a guidewire replacement device which has a proximal tubular section having proximal and distal ends, and a distal tubular section having proximal and distal ends, with the proximal end of the distal tubular section being secured to the distal end of the proximal tubular section and having a proximal guidewire port and with the distal end of the distal tubular section having a distal guidewire port and being adapted to be seated into a proximal guidewire port of an intravascular catheter;    b) advancing the guidewire replacement device over the guidewire until the distal end of the guidewire replacement device is seated within the proximal guidewire port in the catheter through which the guidewire exits;    c) withdrawing the in-place guidewire;    d) advancing a replacement guidewire through an inner lumen extending within the guidewire replacement device, through the proximal guidewire port in the catheter and out the distal guidewire port in the catheter;    e) withdrawing the guidewire replacement device from the patient;    f) peeling the guidewire replacement device from the replacement guidewire through a slit provided in the wall of the proximal tubular section of the guidewire replacement device as it exits the patient; and    g) further withdrawing the guidewire placement device over the replacement guidewire until the distal end of the placement device exits the patient, manually securing the exposed portion of the replacement guidewire distal to the distal end of the placement device and then removing the placement device from the replacement guidewire.    
     
     
         15 . An intraluminal catheter adapted to exchange an in-place guidewire with a replacement guidewire, comprising: 
 a) an elongated shaft having a proximal section with an inner lumen extending therein and a distal section with an inner lumen extending therein;    b) a junction between the proximal and distal shaft sections which includes a proximal guidewire port which is in communication with the inner lumen of the distal shaft section and which is offset from the inner lumen in the proximal shaft section.    
     
     
         16 . The catheter of  claim 15  wherein the distal and proximal shaft sections are disposed at a slight angle with respect to one another.  
     
     
         17 . The catheter of  claim 15  wherein the distal and proximal shaft sections are separate tubular elements and the junction therebetween includes a sleeve having a distal end secured to the proximal end of the tubular element forming the distal shaft section and an enlarged proximal end which is partially secured to the distal end of the tubular element forming the proximal shaft section and which defines the proximal guidewire port.  
     
     
         18 . The catheter of  claim 16  wherein the angle is about 5 to about 40 degrees.  
     
     
         19 . The catheter of  claim 18  wherein the angle is not more than about 30 degrees.