Low radial force vascular device and method of occlusion

Abstract

An occlusion apparatus comprises inner and outer sheaths and an expandable flexible tubular sleeve. The occlusion apparatus is advanced to a target site in the blood vessel. A dilator having a soft, compressible tip may be advanced through a lumen of the inner sheath to facilitate the advancement of the occlusion apparatus. The sheaths are translated relative to one another to expand the flexible tubular sleeve to a funnel shape with a distal flush portion contacting the blood vessel inner wall and a proximal tapered portion. The proximal portion is fluid permeable so that blood can pass through to apply pressure on the vessel wall through the distal portion. A capture or traction device can be advanced out of the inner sheath lumen and retracted back therein to capture thrombus. The distal portion of the device may comprise an expandable mesh braid with a memory characteristic to limit expansion.

What is claimed is: 
     
         1 . An occlusion apparatus for occluding a bodily vessel, the apparatus comprising:
 an outer sheath;   an inner sheath; and   a flexible tubular sleeve having a contracted configuration and an expanded configuration,   wherein the outer sheath and the inner sheath are translatable relative to one another to actuate the flexible tubular sleeve between the contracted and expanded configurations,   wherein the flexible tubular sleeve in the expanded configuration has a funnel shape with a distal flush portion adapted to contact an inner wall of the bodily vessel when the flexible tubular sleeve is expanded therein and a proximal tapered portion, and   wherein at least a part of the proximal tapered portion is fluid permeable such that bodily fluid within the bodily vessel can pass through the fluid permeable part to apply pressure on the inner wall of the bodily vessel through the distal flush portion.   
     
     
         2 . The apparatus of  claim 1 , wherein the inner sheath is disposed at least partially within the outer sheath. 
     
     
         3 . The apparatus of  claim 1 , wherein the flexible tubular sleeve has a first end and a second end, wherein the first end is coupled to a distal end of inner sheath or the second end is coupled to a distal end of the outer sheath. 
     
     
         4 . The apparatus of  claim 1 , wherein a distal end of the inner sleeve is distal of a distal end of the outer sleeve when the flexible tubular sleeve is in the contracted configuration. 
     
     
         5 . The apparatus of  claim 1 , wherein the flexible tubular sleeve is biased to assume the expanded configuration with the funnel shape. 
     
     
         6 . The apparatus of  claim 1 , wherein at least a part of the distal flush portion is fluid impermeable, the fluid impermeable part of the distal flush portion being distal of the fluid permeable part of the proximal tapered portion when the flexible tubular sleeve is in the expanded configuration. 
     
     
         7 . The apparatus of  claim 1 , wherein the flexible tubular sleeve comprises a mesh braid. 
     
     
         8 . The apparatus of  claim 1 , wherein the flexible tubular sleeve comprises a U-shaped direction-reversing region adapted to move relative to one or more of the inner and outer sheaths as the inner and outer sheaths are translated relative to one another. 
     
     
         9 . The apparatus of  claim 1 , wherein the distal flush portion of the flexible tubular sleeve in the expanded configuration is adapted to apply a radially outward force sufficient to occlude fluid flow in the bodily vessel. 
     
     
         10 . A system for treating a disease within a bodily vessel, the system comprising:
 the occlusion apparatus of  claim 1 ; and one or more of   a dilator advancable at least partially through a lumen of the inner sheath of the occlusion apparatus so that a distal tip of the dilator is distal of the occlusion apparatus, the dilator having a malleable and oversized distal tip with a greater cross-sectional area than a distal tip of the inner sheath of the occlusion apparatus; or   a fraction apparatus translatable at least partially through the lumen of the inner sheath so that an expandable mesh braid on a distal portion of the traction apparatus can be positioned and expanded distal of the occlusion apparatus.   
     
     
         11 . The system of  claim 11 , wherein the expandable mesh braid is configured to apply a predetermined limited amount of radially outward force when expanded in the bodily vessel and elongate to minimize distending or damaging the bodily vessel as the expandable mesh braid is expanded. 
     
     
         12 . A method of treating a bodily vessel, the method comprising:
 advancing an occlusion apparatus to a target site in a bodily vessel; and   expanding a flexible tubular sleeve of the occlusion apparatus to a funnel shaped expanded configuration occluding the bodily vessel at the target site,   wherein a distal flush portion of the flexible tubular sleeve contacts an inner wall of the bodily vessel when expanded, and   wherein a proximal tapered portion of the flexible tubular sleeve allows bodily fluid within the bodily vessel to pass at least partially therethrough to apply pressure on the inner wall of the bodily vessel through the distal flush portion.   
     
     
         13 . The method of  claim 12 , wherein expanding the flexible tubular sleeve comprises translating an inner sheath and an outer sheath of the occlusion apparatus relative to one another. 
     
     
         14 . The method of  claim 13 , wherein translating the inner and outer sheaths relative to one another moves a U-shaped direction reversing region of the flexible tubular sleeve relative to one or more of the inner or outer sheaths. 
     
     
         15 . The method of  claim 12 , wherein the distal flush portion of the flexible tubular sleeve in the expanded configuration is adapted to apply a radially outward force sufficient to occlude fluid flow in the bodily vessel. 
     
     
         16 . The method of  claim 15 , wherein the radially outward force is combined with the pressure from the bodily fluid passed through the proximal tapered portion. 
     
     
         17 . The method of  claim 12 , wherein the flexible tubular sleeve is biased to assume the funnel shaped expanded configuration, and wherein expanding the flexible tubular sleeve comprises allowing the flexible tubular sleeve to assume the funnel shaped expanded configuration. 
     
     
         18 . The method of  claim 12 , wherein the occlusion apparatus is advanced over a guide wire. 
     
     
         19 . The method of  claim 12 , further comprising advancing a dilator through the occlusion apparatus. 
     
     
         20 . The method of  claim 19 , further comprising retracting the dilator within the bodily vessel to capture and retract material in the bodily vessel into an inner lumen of the occlusion apparatus. 
     
     
         21 . The method of  claim 20 , wherein the dilator has a malleable and oversized distal tip having a greater cross-sectional area than a distal tip of the inner sheath of the occlusion apparatus. 
     
     
         22 . The method of  claim 12 , further comprising advancing a traction apparatus through the occlusion apparatus, the traction apparatus having an expandable mesh braid on a distal portion thereof. 
     
     
         23 . The method of  claim 22 , further comprising expanding the expandable mesh braid to appose the inner wall of the bodily vessel. 
     
     
         24 . The method of  claim 23 , wherein the expanded expandable mesh braid is configured to apply a limited radially outward force when expanded in the bodily vessel and elongate to minimize distending or damaging the bodily vessel as the tubular outer sleeve is expanded. 
     
     
         25 . The method of  claim 23 , wherein the expandable mesh braid comprises a plurality of wires configured to exert a maximum predetermined outward radial force when the expandable mesh braid is in the expanded configuration. 
     
     
         26 . The method of  claim 22 , further comprising retracting the expanded expandable mesh braid within the bodily vessel to capture and retract material in the bodily vessel into an inner lumen of the occlusion apparatus. 
     
     
         27 . The method of  claim 12 , wherein expanding the flexible tubular sleeve of the occlusion apparatus to the funnel shaped expanded configuration comprises applying a radially outward force from the expanded flexible tubular sleeve to hold the flexible tubular sleeve in place in the bodily vessel. 
     
     
         28 . The method of  claim 27 , wherein the radially outward force comprises blood pressure transmitted through the expanded flexible tubular sleeve and an inherent radially outward force from the expanded flexible tubular sleeve. 
     
     
         29 . The method of  claim 28 , wherein the radially outward force mostly comprises the blood pressure transmitted through the expanded flexible tubular sleeve. 
     
     
         30 . The method of  claim 28 , wherein the blood pressure is transmitted from blood passing through at least a portion of the flexible tubular sleeve.