Percutaneous catheter directed intravascular occlusion devices

Abstract

Embodiments of the present invention provide an improved vascular occlusion device for occlusion of a passageway, cavity, or the like. According to one embodiment, a medical device for occluding a left atrial appendage is provided. The medical device includes a first portion having at least one plane of occlusion that is configured to be positioned outside of the left atrial appendage, and a second portion having at least one plane of occlusion that is configured to be at least partially positioned within a cavity defined by the left atrial appendage.

1 . A medical device for occluding a left atrial appendage, the medical device comprising:
 a first portion comprising at least one plane of occlusion configured to be positioned outside of the left atrial appendage; and   a second portion comprising at least one plane of occlusion configured to be at least partially positioned within a cavity defined by the left atrial appendage.   
     
     
         2 . The medical device of  claim 1 , wherein the at least one plane of occlusion of the first portion is configured to overlie an opening of the left atrial appendage. 
     
     
         3 . The medical device of  claim 1 , wherein the first portion comprises a plurality of planes of occlusion configured to be positioned outside of the left atrial appendage. 
     
     
         4 . The medical device of  claim 1 , wherein the second portion comprises a plurality of planes of occlusion configured to be at least partially positioned within the cavity defined by the left atrial appendage. 
     
     
         5 . The medical device of  claim 1 , wherein the first portion has a first diameter and the second portion has a second diameter that is smaller than the first diameter. 
     
     
         6 . The medical device of  claim 5 , wherein the first diameter is at least about 10% larger than the second diameter. 
     
     
         7 . The medical device of  claim 5 , further comprising a third portion coupled to, and extending distally from, the second portion, wherein the third portion has a third diameter smaller than the second diameter. 
     
     
         8 . The medical device of  claim 5 , further comprising a transition segment coupling the first portion and the second portion and configured to provide flexibility therebetween, the transition segment having a transition diameter substantially smaller than the first and second diameters. 
     
     
         9 . The medical device of  claim 8 , wherein the ratio of the first diameter to the transition diameter is about 6 to 4.5. 
     
     
         10 . The medical device of  claim 8 , wherein the ratio of the second diameter to the transition diameter is about 2 to 4. 
     
     
         11 . The medical device of  claim 1 , wherein the first and second portions comprise at least one layer of occluding material. 
     
     
         12 . The medical device of  claim 11 , wherein the at least one layer of occluding material comprises a woven material. 
     
     
         13 . The medical device of  claim 1 , further comprising a plurality of hooks extending from the second portion and configured to engage the cavity within the left atrial appendage. 
     
     
         14 . The medical device of  claim 13 , wherein the plurality of hooks do not comprise barbs. 
     
     
         15 . The medical device of  claim 1 , wherein the first portion comprises a disk portion and the second portion comprises a cylindrical portion. 
     
     
         16 . The medical device of  claim 1 , wherein the first portion and the second portion are configured to be constrained to a smaller diameter than an expanded preset configuration for delivery to the left atrial appendage and to self expand to the preset configuration when unconstrained. 
     
     
         17 . The medical device of  claim 1 , wherein the at least one plane of occlusion associated with respective first and second portions comprises a metal material, a polyester material, a bio-compatible polymer material, or a combination thereof. 
     
     
         18 . The medical device of  claim 1 , wherein the at least one plane of occlusion associated with respective first and second portions comprises a surface configured to be oriented generally transverse to the flow of blood so as to facilitate the formation of thrombus. 
     
     
         19 . (canceled) 
     
     
         20 . A medical device for occluding a left atrial appendage, the medical device comprising:
 at least one occlusion layer;   wherein the medical device is configured to be constrained within a catheter having an outer diameter of less than 12 French for percutaneous delivery to the left atrial appendage.   
     
     
         21 . The medical device of  claim 20 , wherein the medical device is configured to be constrained within a catheter having an outer diameter of about 11 French or less. 
     
     
         22 . The medical device of  claim 20 , wherein the medical device is configured to be constrained within a catheter having an outer diameter of about 10 French or less. 
     
     
         23 . The medical device of  claim 20 , wherein the medical device is configured to be constrained within a catheter having an outer diameter of about 9 French or less. 
     
     
         24 . A medical device for occluding a left atrial appendage, the medical device comprising:
 at least one plane of occlusion;   wherein said medical device is configured to extend to a depth of about 20 mm or less within the cavity defined by the left atrial appendage.   
     
     
         25 . The medical device of  claim 24 , wherein the medical device is configured to extend to a depth of about 15 mm or less within the cavity defined by the left atrial appendage. 
     
     
         26 . The medical device of  claim 24 , wherein the medical device is configured to extend to a depth of about 10 mm or less within the cavity defined by the left atrial appendage. 
     
     
         27 . A medical device for occluding a left atrial appendage, the medical device comprising:
 a first portion configured to overlie an opening of the left atrial appendage; and   a second portion configured to be at least partially positioned within a cavity defined by the left atrial appendage; and   a transition segment coupling the first portion and the second portion and configured to provide flexibility therebetween, wherein the first portion is configured to flex up to about 30 degrees with respect to the second portion along a central axis extending through the first portion and the second portion.   
     
     
         28 . A medical device for occluding a left atrial appendage, the medical device comprising:
 at least one layer of occlusion;   wherein the medical device is configured to substantially occlude the left atrial appendage in less than about 10 minutes.   
     
     
         29 . The medical device of  claim 28 , wherein the device is configured to substantially occlude the left atrial appendage in less than about 5 minutes. 
     
     
         30 . The medical device of  claim 28 , wherein the device is configured to substantially occlude the left atrial appendage in less than about 3 minutes. 
     
     
         31 . The medical device of  claim 28 , wherein the device is configured to substantially occlude the left atrial appendage in less than about 2 minutes. 
     
     
         32 . The medical device of  claim 28 , wherein the device is configured to substantially occlude the left atrial appendage in less than about 1 minute. 
     
     
         33 . A method for occluding a left atrial appendage with a medical device, the method comprising:
 constraining a medical device to a smaller diameter than an expanded preset configuration, wherein the medical device comprises a first portion having at least one plane of occlusion and a second portion having at least one plane of occlusion;   delivering the medical device proximate to the left atrial appendage; and   deploying the medical device such that the first portion expands and is positioned outside of the left atrial appendage and the second portion expands outwardly to engage at least a portion of a cavity defined within the left atrial appendage.   
     
     
         34 . The method of  claim 33 , wherein constraining comprises constraining the medical device within a catheter, and wherein deploying comprises retracting the catheter proximally relative to the medical device. 
     
     
         35 . The medical device of  claim 34 , further comprising advancing the catheter distally following the deploying step so as to constrain and recapture the medical device within the catheter. 
     
     
         36 . The method of  claim 33 , wherein constraining comprises stretching the medical device along a longitudinal axis thereof to the smaller diameter. 
     
     
         37 . The method of  claim 33 , wherein deploying comprises deploying the medical device such that the first portion overlies an opening of the left atrial appendage. 
     
     
         38 . The method of  claim 33 , further comprising piercing the heart septum prior to delivering the medical device proximate to the left atrial appendage. 
     
     
         39 . The method of  claim 33 , wherein deploying comprises unscrewing a delivery system threadably coupled to the medical device. 
     
     
         40 . The method of  claim 33 , further comprising imaging the left atrial appendage using at least one of two dimensional intracardiac echocardiography, angiography, magnetic resonance imaging, transesphogeal echocardiograpy, or Doppler color flow mapping. 
     
     
         41 . (canceled) 
     
     
         42 . The method of  claim 33 , further comprising verifying occlusion of the left atrial appendage by injecting a radiopaque contrast media through the catheter and into the left atrium adjacent the deployed medical device and observing with angiograghy whether contrast enters the cavity defined by the LAA and further whether any contrast within the cavity is stagnant. 
     
     
         43 . A delivery assembly for delivering a medical device for occluding a left atrial appendage, the delivery assembly comprising:
 a delivery device coupled to the medical device, wherein the medical device comprises at least one plane of occlusion configured to be positioned outside of the left atrial appendage and at least one plane of occlusion configured to be at least partially positioned within a cavity defined by the left atrial appendage; and   a catheter configured to overlie the delivery device and constrain the medical device therein, wherein the catheter is axially displaceable relative to the delivery device.   
     
     
         44 . The delivery assembly of  claim 43 , wherein the medical device comprises at least one layer of occluding material having an expanded preset shape. 
     
     
         45 . The delivery assembly of  claim 43 , wherein the medical device comprises at least one plane of occlusion configured to overlie an opening of the left atrial appendage. 
     
     
         46 . The delivery assembly of  claim 43 , wherein the medical device comprises a plurality of planes of occlusion configured to be positioned outside of the left atrial appendage and a plurality of planes of occlusion configured to be at least partially positioned within the cavity defined by the left atrial appendage. 
     
     
         47 . The delivery assembly of  claim 43 , wherein the catheter has an outer diameter of less than about 11 French. 
     
     
         48 . (canceled) 
     
     
         49 . The delivery assembly of  claim 43 , 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. 
     
     
         50 . The delivery assembly of  claim 49 , wherein the medical device is configured to be recaptured within the catheter in response to displacement of the catheter with respect to the delivery device.