Percutaneous catheter directed intravascular occlusion device

Abstract

Embodiments of the present invention provide medical devices and methods for occluding a target site are provided. For example, the medical device may include a tubular member having proximal and distal ends and at least one plane of occlusion. The at least one plane of occlusion may be configured to substantially occlude the patent ductus arteriosus in less than about 1 minute. In addition or alternatively, the tubular member may consist of a single layer of material and be configured to be constrained within a catheter having an outer diameter of less than about 4 French for percutaneous delivery to the patent ductus arteriosus.

That which is claimed: 
     
         1 . A medical device for occluding a patent ductus arteriosus, the medical device comprising:
 a tubular member having proximal and distal ends and comprising at least one plane of occlusion;   wherein the at least one plane of occlusion is configured to substantially occlude the patent ductus arteriosus in less than about 1 minute.   
     
     
         2 . The medical device of  claim 1 , wherein the tubular member comprises a disk shaped portion having a first cross-sectional dimension on at least one of the proximal and distal ends and an adjacent geometrical shaped portion having a second cross-sectional dimension smaller than the first cross-sectional dimension. 
     
     
         3 . The medical device of  claim 2 , wherein the geometrical shaped portion is a cylinder. 
     
     
         4 . The medical device of  claim 2 , further comprising a transition segment disposed between the disk shaped portion and the geometrical shaped portion, wherein the disk and geometrical shaped portions are connected by the transition segment having a cross-sectional dimension smaller than both the disk diameter and geometrical shaped portion cross-sectional dimension. 
     
     
         5 . The medical device of  claim 4 , wherein the tubular member comprises a frustroconical shaped disk on each of the proximal and distal ends, and wherein the geometrical shaped portion is disposed therebetween and connected to the frustroconical shaped disks with respective transition segments. 
     
     
         6 . The medical device of  claim 1 , wherein the tubular member comprises at least one layer of braided fabric comprising a plurality of braided metal strands. 
     
     
         7 . The medical device of  claim 6 , wherein the tubular member comprises a plurality of layers of braided fabric, each layer comprising a plurality of braided metal strands. 
     
     
         8 . The medical device of  claim 6 , wherein the metal strands comprise a material selected from the group consisting of stainless steel, nickel based, cobalt based, nickel-titanium, shape memory, and super-elastic materials. 
     
     
         9 . The medical device of  claim 1 , wherein the tubular member is configured to be constrained within a catheter having an outer diameter of about 5 French or smaller for percutaneous delivery. 
     
     
         10 . The medical device of  claim 1 , wherein the tubular member comprises a plurality of planes of occlusion. 
     
     
         11 . The medical device of  claim 10 , wherein a plurality of planes of occlusion are configured to be positioned outside of the patent ductus arteriosus and a plurality of planes of occlusion are configured to be positioned within a cavity defined by the patent ductus arteriosus. 
     
     
         12 . A medical device for occluding a patent ductus arteriosus, the medical device comprising:
 a tubular member having proximal and distal ends and consisting of a single layer of braided fabric;   wherein the single layer of braided fabric is configured to be constrained within a catheter having an outer diameter of about 5 French or smaller for percutaneous delivery to the patent ductus arteriosus.   
     
     
         13 . The medical device of  claim 12 , wherein the tubular member comprises a disk shaped portion having a first cross-sectional dimension on at least one of the proximal and distal ends and an adjacent geometrical shaped portion having a second cross-sectional dimension smaller than the first cross-sectional dimension. 
     
     
         14 . The medical device of  claim 13 , further comprising a transition segment disposed between the disk shaped portion and the geometrical shaped portion, wherein the disk and cylindrical portions are connected by the transition segment having a cross-sectional dimension smaller than both the disk diameter and geometrical shaped portion cross-sectional dimension. 
     
     
         15 . The medical device of  claim 12 , wherein the single layer of braided fabric comprises a plurality of braided metal strands. 
     
     
         16 . The medical device of  claim 12 , wherein the tubular member is configured to be constrained within a catheter having an outer diameter of about 4 French or smaller for percutaneous delivery. 
     
     
         17 . The medical device of  claim 16 , wherein the metal strands comprise a material selected from the group consisting of stainless steel, nickel based, cobalt based, nickel-titanium, shape memory, and super-elastic materials. 
     
     
         18 . The medical device of  claim 12 , wherein the tubular member comprises at least one plane of occlusion configured to substantially occlude the patent ductus arteriosus in less than about 1 minute. 
     
     
         19 . A delivery system for delivering a medical device for occluding a patent ductus arteriosus, the delivery system comprising:
 a delivery device coupled to the medical device, wherein the medical device consists of a single layer of braided fabric; and   a catheter configured to overlie the delivery device and constrain the medical device therein, wherein the medical device is configured to be deployed from the catheter, and wherein the delivery device and catheter are configured to be delivered bi-directionally to the patent ductus arteriosus either transarterially or transvenously and to deploy the medical device at least partially within the patent ductus arteriosus.   
     
     
         20 . The delivery system of  claim 19 , wherein the medical device comprises a plurality of planes of occlusion configured to be positioned outside of the patent ductus arteriosus and a plurality of planes of occlusion configured to be positioned within a cavity defined by the patent ductus arteriosus. 
     
     
         21 . The delivery system of  claim 19 , wherein the catheter has an outer diameter of about 5 French. 
     
     
         22 . The delivery system of  claim 19 , wherein the catheter has an outer diameter of about 4 French or smaller. 
     
     
         21 . The delivery system of  claim 19 , wherein the delivery device and catheter are configured to be delivered to the patent ductus arteriosus over a guidewire. 
     
     
         22 . The delivery system of  claim 19 , wherein the catheter is axially displaceable relative to the delivery device such that the medical device is configured to be deployed from the catheter in response to displacement of the catheter with respect to the delivery device. 
     
     
         23 . The delivery system of  claim 19 , wherein the medical device is configured to substantially preclude the patent ductus arteriosus in less than about 1 minute. 
     
     
         26 . A method for occluding a patent ductus arteriosus, the method comprising:
 providing a medical device consisting of a single layer of braided fabric;   constraining the medical device from a preset expanded configuration to a reduced configuration;   positioning the constrained medical device in a catheter, the catheter and device configured to be delivered bi-directionally, either transarterially or transvenously;   delivering the medical device to the patent ductus arteriosus either transarterially or transvenously; and   deploying the medical device from the catheter at least partially within the patent ductus arteriosus such that the tubular member returns to the preset expanded configuration.   
     
     
         27 . The method of  claim 26 , wherein the medical device comprises a plurality of planes of occlusion, and wherein deploying comprises deploying the medical device such that at least one plane of occlusion is positioned outside the patent ductus arteriosus and at least one plane of occlusion is positioned within a cavity defined within the patent ductus arteriosus. 
     
     
         28 . The method of  claim 26 , wherein deploying comprises detaching a delivery system positioned within the catheter and coupled to the medical device. 
     
     
         29 . The method of  claim 26 , wherein delivering comprises delivering the medical device over a guide wire. 
     
     
         30 . The method of  claim 26 , further comprising imaging the patent ductus arteriosus using at least one of two-dimensional intracardiac echocardiography, angiography, magnetic resonance imaging, transesphogeal echocardiograpy, or Doppler color flow mapping. 
     
     
         31 . The method of  claim 26 , further comprising verifying occlusion of the patent ductus arteriosus by injecting a radiopaque contrast media through the catheter and into the aorta downstream of the deployed medical device and observing with angiography whether contrast enters the cavity defined by the patent ductus arteriosus and further whether any contrast within the cavity is stagnant.