Occlusion devices and methods of their manufacture and use

Abstract

Disclosed are implantable medical devices for the occlusion of a bodily lumen, cavity, vessel, or organ, as well as methods for manufacturing such occlusion devices, and methods for treating a subject using the occlusion devices. The devices generally include a wire having shape memory properties and a flexible membranous material disposed about the wire. Some embodiments include a lateral fringe on the membranous material. Some embodiments include a fluid capture cup affixed to the wire.

What is claimed is: 
     
         1 . A device for limiting fluid flow through a lumen in a bodily tissue, comprising:
 at least one wire with proximal and distal ends; and   a flexible polymeric cup, wherein the flexible polymeric cup includes an open end affixed to the proximal end of the wire, wherein the flexible polymeric cup is adapted to be reconfigured during deployment into the lumen from a pre-deployed state to an everted state, and wherein the flexible polymeric cup in the everted state is adapted to limit fluid flow through the lumen.   
     
     
         2 . A method for occluding a lumen in a bodily tissue, comprising:
 providing an occlusion device, wherein the occlusion device comprises:
 at least one wire with proximal and distal ends; and 
 a flexible polymeric cup, wherein the flexible polymeric cup includes an open end affixed to the proximal end of the wire, wherein the flexible polymeric cup is adapted to be reconfigured during deployment into the lumen from a pre-deployed state to an everted state, and wherein the flexible polymeric cup in the everted state is adapted to occlude the lumen; 
   providing a delivery sheath, wherein the delivery sheath comprises a delivery lumen;   configuring, within the delivery lumen, the occlusion device in the pre-deployed state;   delivering the delivery lumen including the occlusion device in the pre-deployed state to a target site within the lumen; and   deploying the occlusion device at the target site within the lumen, wherein the deploying comprises:
 ejecting the occlusion device from the delivery lumen; and 
 reconfiguring the flexible polymeric cup from the pre-deployed state to the everted state. 
   
     
     
         3 . The method of  claim 2 , wherein the reconfiguring of the flexible polymeric cup from the pre-deployed state to the everted state is caused at least partially by pressure exerted by fluid against the flexible polymeric cup. 
     
     
         4 . The method of  claim 3 , wherein the reconfiguring of the flexible polymeric cup from the pre-deployed state to the everted state is caused at least partially by pressure exerted by a device against the flexible polymeric cup. 
     
     
         5 . The device of  claim 1 , wherein the flexible polymeric cup is formed from a sheet of polymeric material. 
     
     
         6 . The device of  claim 1 , wherein the flexible polymeric cup is formed from a tube of polymeric material. 
     
     
         7 . The device of  claim 1 , wherein the flexible polymeric cup comprises ePTFE. 
     
     
         8 . The device of  claim 7 , wherein the ePTFE is coated with FEP. 
     
     
         9 . The device of  claim 1 , further comprising one or more radiopaque markers. 
     
     
         10 . The device of  claim 1 , wherein the frame defines a wire-framed cylinder having a first open end and a second open end. 
     
     
         11 . The method of  claim 2 , wherein deploying the occlusion device includes moving a pusher catheter to induce movement of the flexible polymeric cup from the delivery lumen. 
     
     
         12 . The method of  claim 2 , wherein deploying the occlusion device includes moving the delivery sheath while a pusher catheter is maintained stationary such that the flexible polymeric cup remains stationary and is deployed from the delivery lumen.