Exchange method for emboli containment

Abstract

The present invention provides a method for exchanging catheters while containing emboli within a blood vessel such as a saphenous vein graft, coronary artery, carotid artery, or other similar vessels. A guidewire is inserted through the vasculature of a patient until it reaches a desired treatment site. A therapy catheter is then inserted over the guidewire until the distal end of the therapy catheter reaches the treatment site. The guidewire has a distally mounted balloon which is inflated to occlude the blood vessel. Then, the therapy catheter provides means for treating the vessel at the treatment site. After treatment, the therapy catheter is removed from the guidewire and exchanged with an aspiration catheter which rides over the guidewire until the distal end of the aspiration catheter reaches the treatment site. The aspiration catheter applies negative pressure to remove any emboli formed by the treatment procedure.

1 . A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising: 
 (a) delivering a flexible elongate member having a proximal extremity, a distal extremity, and an expandable member into the vasculature of a patient until the distal extremity is near to a treatment site in the blood vessel, the expandable member disposed about the distal extremity, the expandable member being actuatable between an expanded state and a nonexpanded state;    (b) actuating the expandable member at a location distal to the treatment site from its nonexpanded state to its expanded state;    (c) delivering a therapy catheter comprising an elongate catheter shaft having a proximal extremity, a distal extremity, and at least one lumen, over the flexible elongate member until the distal extremity of the therapy catheter is near to the treatment site;    (d) performing treatment on the treatment site with the therapy catheter, said treatment resulting in the presence of emboli in the blood vessel at the treatment site;    (e) removing the therapy catheter from the flexible elongate member;    (f) delivering a second catheter comprising an elongate catheter shaft having a proximal extremity, a distal extremity, and at least one lumen, over the flexible elongate member until the distal extremity of the second catheter is near to the treatment site; and    (g) removing emboli from the blood vessel within the second catheter;    wherein the expandable member is in its expanded state distal to the treatment site continuously at least from step (d) to step (f) to prevent emboli from moving downstream.    
   
   
       2 . The method of  claim 1 , wherein the expandable member is an inflatable balloon.  
   
   
       3 . The method of  claim 1 , wherein the expandable member is a self-expanding member.  
   
   
       4 . The method of  claim 1 , wherein the expandable member is a filter.  
   
   
       5 . The method of  claim 4 , wherein the filter is self-expandable.  
   
   
       6 . The method of  claim 4 , wherein the filter is mechanically-deployed  
   
   
       7 . The method of  claim 1 , wherein the expandable member is a mechanically deployed member.  
   
   
       8 . The method of  claim 1 , wherein the therapy catheter is delivered independently of the flexible elongate member.  
   
   
       9 . The method of  claim 1 , wherein the therapy catheter is delivered simultaneously with the flexible elongate member.  
   
   
       10 . The method of  claim 1 , wherein the therapy catheter is delivered while the expandable member is in its nonexpanded state.  
   
   
       11 . The method of  claim 1 , wherein the therapy catheter has a dilatation balloon mounted on its distal extremity for compressing plaque found on the walls of the blood vessel.  
   
   
       12 . The method of  claim 1 , wherein the therapy catheter performs treatment selected from the group consisting of stent delivery, drug delivery, atherectomy, shock wave generation, laser ablation, ultrasound ablation, vibration delivery and embolization element delivery for treatment of an aneurysm.  
   
   
       13 . The method of  claim 1 , wherein the therapy catheter includes a lumen which is sized to override the flexible elongate member.  
   
   
       14 . The method of  claim 1 , wherein the flexible elongate member is hollow.  
   
   
       15 . A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising: 
 (a) delivering a flexible elongate member having a proximal extremity, a distal extremity, and an expandable member into the vasculature of a patient until the distal extremity is near to a treatment site in the blood vessel, the expandable member disposed about the distal extremity, the expandable member being actuatable between an expanded state and a nonexpanded state;    (b) delivering a first therapy catheter comprising an elongate catheter shaft having a proximal extremity, a distal extremity, and at least one lumen, over the flexible elongate member until the distal extremity of the first therapy catheter is near to the treatment site;    (c) performing treatment on the treatment site with the first therapy catheter, said treatment resulting in the presence of emboli in the blood vessel at the treatment site;    (d) delivering a second therapy catheter comprising an elongate catheter shaft having a proximal extremity, a distal extremity, and at least one lumen, over the flexible elongate member until the distal extremity of the second therapy catheter is near to the treatment site; and    (e) performing treatment on the treatment site with the second therapy catheter, said treatment resulting in the presence of emboli in the blood vessel at the treatment site; and    (f) removing emboli from the blood vessel;    wherein the expandable member is in its expanded state distal to the treatment site continuously at least from step (c) to step (e) to prevent emboli from moving downstream.    
   
   
       16 . The method of  claim 15 , wherein the expandable member is an inflatable balloon.  
   
   
       17 . The method of  claim 15 , wherein the expandable member is a self-expanding member.  
   
   
       18 . The method of  claim 15 , wherein the expandable member is a filter.  
   
   
       19 . The method of  claim 18 , wherein the filter is self-expandable.  
   
   
       20 . The method of  claim 18 , wherein the filter is mechanically-deployed  
   
   
       21 . The method of  claim 15 , wherein the expandable member is a mechanically deployed member.  
   
   
       22 . The method of  claim 15 , wherein the first therapy catheter is delivered independently of the flexible elongate member.  
   
   
       23 . The method of  claim 15 , wherein the first therapy catheter is delivered simultaneously with the flexible elongate member.  
   
   
       24 . The method of  claim 15 , wherein the first therapy catheter is delivered while the expandable member is in its nonexpanded state.  
   
   
       25 . The method of  claim 15 , wherein the first therapy catheter has a dilatation balloon mounted on its distal extremity for compressing plaque found on the walls of the blood vessel.  
   
   
       26 . The method of  claim 25 , wherein the second therapy catheter has a dilatation balloon with a second diameter larger than the first diameter mounted on its distal end for compressing plaque found on the walls of the blood vessel.  
   
   
       27 . The method of  claim 15 , wherein the first therapy catheter performs treatment selected from the group consisting of stent delivery, drug delivery, atherectomy, shock wave generation, laser ablation, ultrasound ablation, vibration delivery and embolization element delivery for treatment of an aneurysm.  
   
   
       28 . The method of  claim 15 , wherein the second therapy catheter performs treatment selected from the group consisting of stent delivery, drug delivery, atherectomy, shock wave generation, laser ablation, ultrasound ablation, vibration delivery and embolization element delivery for treatment of an aneurysm.  
   
   
       29 . The method of  claim 15 , wherein the first and second therapy catheters include a lumen which is sized to override the flexible elongate member.  
   
   
       30 . The method of  claim 15 , wherein the flexible elongate member is hollow.