Devices and methods for percutaneous tissue removal

Abstract

Devices and methods are provided for percutaneously treating atherosclerotic plaques within blood vessels. Atherosclerotic plaques cause significant morbidity and mortality by narrowing the arteries, which adversely affects blood flow, and by acting as a source for thrombi and emboli thus causing acute organ ischemia. Current treatments include open surgery with its inherent drawbacks, and stenting, which is less invasive but leaves the plaque material in the artery, which promotes restenosis. The present invention combines the advantages of both approaches. In general, the invention provides tools that enable percutaneously dissecting the plaque from the arterial wall and removing it from the body.

1 - 47 . (canceled) 
     
     
         48 . A device for percutaneous endarterectomy comprising:
 a catheter having a lumen;   one or more guidewires for threading through a subintimal space of an artery, wherein the guidewires pass through the lumen of the catheter; and   an expandable separator device comprising a hollow cylinder folded onto an elongated member, wherein the separator when deployed assumes a cylindrical shape with an overlap of both ends over a slit.   
     
     
         49 . The device of  claim 48  wherein the expansion of the separator device separates a plaque from the arterial wall. 
     
     
         50 . The device of  claim 48  further comprising a cutting tool. 
     
     
         51 . The device of  claim 48  further comprising a grinder mounted on a distal end of the catheter. 
     
     
         52 . The device of  claim 48  further comprising a grinder deployable through the lumen of the catheter. 
     
     
         53 - 58 . (canceled) 
     
     
         59 . A device for inserting one or more guidewires into a subintimal space of an artery comprising:
 a catheter having a lumen, a distal end and a tip at the distal end;   a pushing element at the tip of said catheter;   a balloon proximal to said pushing element; and   one or more guidewire catheters adjacent and parallel to said catheter, said guidewire catheter passing over balloon and configured to assume an orientation essentially parallel to longitudinal axis of distal catheter or up to approximately 5 degrees outward of said axis.   
     
     
         60 . The device of  claim 59 , wherein said pushing element is a balloon. 
     
     
         61 . The device of  claim 60 , wherein said balloon is moveable relative to said catheter. 
     
     
         62 . The device of  claim 59 , wherein pushing element comprises an expandable metal element. 
     
     
         63 . A method for inserting one or more guidewires into subintimal space, comprising identifying a lesion, bringing the device of  59  proximate to lesion, inflating proximal balloon, applying tension by the pushing element, pushing guidewire forward into subintimal space. 
     
     
         64 . The method of  claim 63  further comprising application of suction on the area between the proximal and distal balloon prior to the pushing the guidewire into subintimal space. 
     
     
         65 . The method of  claim 63  further comprising verification of guidewire insertion into subintimal space by use of angiography. 
     
     
         66 . A method for removal of a plaque comprising inserting one or more guidewires using the device of  claim 59  and rotating the one or more guidewires around the plaque, first forward until the one or more guidewires re-enter the lumen and then backwards to remove the plaque. 
     
     
         67 . The device of  claim 48  wherein the expandable separator further comprises an inflatable balloon constructed of multiple longitudinal chambers having a trapezoid cross-section and connected to each other side by side. 
     
     
         68 . The device of  claim 48  wherein the guidewire is configured to extend through a lumen of the artery on the proximal side and distal side of a lesion and is configured to extend through the subintimal space along the length of the lesion. 
     
     
         69 . The device of  claim 48  further comprising one or more markers, the one or more markers configured to ascertain the orientation of the device. 
     
     
         70 . The device of  claim 48  wherein the expandable separator further comprises transverse longitudinal strips, each having a slight curvature, such that when inflated, the device assumes a flat shape with only slight radius of curvature. 
     
     
         71 . The device of  claim 48  wherein the expandable separator further comprises multiple arched wires stemming off both sides of a central longitudinal spine, and a sheath covering the arched wires, wherein the sheath is configured to hold the arched wires flat adjacent to the spine in an undeployed position. 
     
     
         72 . The device of  claim 71  wherein the arched wires are formed of nitinol. 
     
     
         73 . A method of percutaneous endarterectomy comprising:
 (a) accessing an artery having an atherosclerotic plaque nearby the plaque with a device comprising:
 a shaft configured to pass through the lumen of a catheter, having a distal end, and 
 one or more expandable fingers having a proximal and distal end with the proximal end of the one or more fingers attached to the distal end of the shaft, 
 wherein the fingers are configured to remove an atherosclerotic plaque by peeling the plaque at the subintimal space without performing an incision into the subintimal space and without use of a blade, 
 wherein the distal end of the expandable fingers when expanded is substantially parallel to the shaft; 
   (b) peeling the plaque at the subintimal space without performing an incision into the subintimal space and without use of a blade;   (c) separating the plaque from the arterial wall around its circumference and along its length;   (d) cutting the intima connecting the distal part of the plaque to the arterial wall; and   (e) locally treating the exposed media after cutting by instillation of endothelial progenitor cells, stem cells, other cells or substances.