Pedal thromboembolic protection device

Abstract

Disclosed herein are embolism protection devices that may be deployed in the peripheral arterial system for the collection of loosened or floating debris, such as embolic material dislodged during or thrombi formed as a result of a peripheral intervention, such as an angioplasty, stenting, or atherectomy. The disclosed embolism protection devices are designed to be inserted distal to lesion in a lower limb artery via one of the arteries of the foot, such as the dorsalis pedis, posterior tibialis, or peroneal (fibular) artery, and they include a compliant mesh portion supported by a compliant wire support member, and the compliant mesh portion extends to form or couples to a solid catheter portion that extends out of the body during use, and that may be coupled to a stopcock or syringe for removal of debris.

What is claimed is: 
     
         1 . An intravascular embolism protection device comprising:
 a compliant mesh portion comprising a funnel shape and having an open distal end and an apex generally opposite the open distal end, the compliant mesh portion having a pore size selected to allow blood to pass therethrough while restricting the passage of potential emboli;   a compliant wire support member comprising a material having a shape-memory function; the compliant wire support member being coupled to the compliant mesh portion and biasing the compliant mesh portion in and open position;   a catheter portion extending from the apex and having a lumen in communication with an aperture in the apex;   wherein the embolism protection device has a collapsed state wherein the embolism protection device fits within the lumen of a deployment catheter, and an expanded state wherein the compliant mesh portion is sized to span the width of an artery of the foot.   
     
     
         2 . The intravascular embolism protection device of  claim 1 , wherein the artery of the foot is a dorsalis pedis. 
     
     
         3 . The intravascular embolism protection device of  claim 1 , wherein the artery of the foot is a posterior tibialis. 
     
     
         4 . The intravascular embolism protection device of  claim 1 , wherein the artery of the foot is a peroneal (fibular) artery. 
     
     
         5 . The intravascular embolism protection device of  claim 1 , wherein the embolism protection device has a width dimension in the expanded state of about 3-7 mm. 
     
     
         6 . The intravascular embolism protection device of  claim 1 , wherein the mesh material has a pore size of about 80-100 mm. 
     
     
         7 . The intravascular embolism protection device of  claim 1 , wherein the mesh material has a pore size of about 100 mm. 
     
     
         8 . The intravascular embolism protection device of  claim 1 , wherein the catheter portion has a proximal end and a distal end, wherein the distal end comprises a coupling element. 
     
     
         9 . The intravascular embolism protection device of  claim 1 , wherein coupling element is a threaded coupler. 
     
     
         10 . The intravascular embolism protection device of  claim 1 , wherein coupling element is a Luer-lock coupler. 
     
     
         11 . A kit for preventing embolisms during a peripheral artery intervention, the kit comprising:
 a deployment catheter having a proximal end and a distal end and being sized to be inserted into an artery of the foot;   an intravascular embolism protection device comprising:
 a compliant mesh portion comprising a funnel shape and having an open distal end and an apex generally opposite the open distal end, the compliant mesh portion having a pore size selected to allow blood to pass therethrough while restricting the passage of potential emboli; 
 a compliant wire support member comprising a material having a shape-memory function; the compliant wire support member being coupled to the compliant mesh portion and biasing the compliant mesh portion in and open position; 
 a catheter portion extending from the apex and having a lumen in communication with an aperture in the apex; 
 wherein the embolism protection device has a collapsed state wherein the embolism protection device fits within the lumen of a deployment catheter, and an expanded state wherein the compliant mesh portion is sized to span the width of an artery of the foot; and 
   a debris removal device configured to couple to a distal end of the catheter portion.   
     
     
         12 . The kit of  claim 11 , wherein the debris removal device comprises a stopcock. 
     
     
         13 . The kit of  claim 11 , wherein the debris removal device comprises a syringe. 
     
     
         14 . A method of protecting a subject from embolism during a peripheral artery procedure, comprising:
 advancing a guidewire through the vasculature of the subject through a puncture site in an artery of a foot;   advancing a catheter and an embolism protection device compressed within the catheter along the guidewire to a position adjacent a peripheral arterial lesion, the catheter having a proximal end and a distal end;   wherein the embolism protection device comprises:
 a compliant mesh portion comprising a funnel shape and having an open distal end and an apex generally opposite the open distal end, the compliant mesh portion having a pore size selected to allow blood to pass therethrough while restricting the passage of potential emboli; 
 a compliant wire support member comprising a material having a shape-memory function; the compliant wire support member being coupled to the compliant mesh portion and biasing the compliant mesh portion in and open position; 
 a catheter portion extending from the apex and having a lumen in communication with an aperture in the apex; 
 wherein the embolism protection device has a collapsed state wherein the embolism protection device fits within the lumen of a deployment catheter, and an expanded state wherein the compliant mesh portion is sized to span the width of an artery of the foot; 
   withdrawing the catheter through the puncture site in the artery of the foot, thereby allowing the embolism protection device to self-expand;   performing the peripheral artery procedure; and   removing the embolism protection device from the vasculature of the subject.   
     
     
         15 . The method of  claim 14 , wherein the artery of the foot is a dorsalis pedis, a posterior tibialis, or a peroneal (fibular) artery. 
     
     
         16 . The method of  claim 14 , wherein the steps of (1) advancing a catheter along the guidewire to a position adjacent a peripheral arterial lesion; and (2) advancing an embolism protection device compressed within the catheter occur simultaneously. 
     
     
         17 . The method of  claim 14 , wherein the steps of (1) advancing a catheter along the guidewire to a position adjacent a peripheral arterial lesion; and (2) advancing an embolism protection device compressed within the catheter occur sequentially. 
     
     
         18 . The method of  claim 14 , wherein the method further comprises coupling an evacuation device to a distal end of the catheter portion of the embolism protection device. 
     
     
         19 . The method of  claim 18 , wherein the method further comprises using the evacuation device to remove debris from the embolism protection device.