Over-the-wire exclusion device and system for delivery

Abstract

A modification to allow delivery of a two port medical flow restrictor over a guidewire, and a means to mechanically collapse the new device. A thin walled, foil-like shell, is compacted for delivery. The invention includes the device, delivery assemblies, and methods of placing, and using, the device. A device with an aneurysm lobe and an artery lobe self-aligns its waist at the neck of an aneurysm as the device shell is pressure expanded. Mechanical force collapses both the aneurysm lobe and the artery lobe, captivating the neck of the aneurysm and securing the device. The device works for aneurysms at bifurcations and aneurysms near side-branch arteries. The device, unlike endovascular coiling, excludes the weak neck of the aneurysm from circulation, while leaving the aneurysm relatively empty. Unlike stent-based exclusion, the device does not block perforator arteries. This exclusion device can also limit flow through body lumens or orifices.

1 - 10 . (canceled) 
     
     
         11 . An exclusion device comprising:
 a hollow foil-like shell capable of containing pressure and having a proximal end, a distal end and a longitudinal axis defined between the proximal and distal ends, and   a pressure tube detachably attached to the shell and comprising a pressure port configured to communicate pressure to the inside of said shell, the pressure tube being a fluid tight communication with the proximal stern and the pressure port being at or proximal to the proximal end of the shell, the shell having the capability of transitioning from a manufactured shape to a compacted shape to an inflated balloon shape upon delivery of positive pressure into the shell,   the shell having the property of retaining the inflated balloon shape upon removal of the positive pressure causing the shell to assume the balloon shape, and   apparatus for guiding the exclusion device to a desired location while the shell is in the compacted shape, the pressure tube delivering positive pressure to the shell via the pressure port of the pressure tube to expand the shell to the-inflated balloon shape.   
     
     
         12 . The exclusion device of claim  1  wherein the shell comprises a ductile metal. 
     
     
         13 . The exclusion device of claim  1  wherein the shell is formed from electroformed metal. 
     
     
         14 . The exclusion device of claim  1  wherein the pressure tube is movable proximally to the proximal stem. 
     
     
         15 . The exclusion device of claim  1  which comprises an airtight attachment between the pressure tube and the shell. 
     
     
         16 . The exclusion device of claim  1  wherein the pressure tube can be disconnected from the shell by pulling the pressure tube proximally and pushing a-pusher tube distally until the pressure tube shears from the shell. 
     
     
         17 . The exclusion device of claim  1  including an outer sheath covering the pressure tube. 
     
     
         18 . A method of occluding a predetermined lumen or orifice in a human body which comprises:
 (a) providing an exclusion device comprising:   a hollow foil-like shell capable of containing pressure and having a proximal end, a distal end and a longitudinal axis defined between the proximal and distal ends, and   a pressure tube detachably attached to the shell and comprising a pressure port configured to communicate pressure to the inside of said shell, the shell being capable of transitioning from a manufactured shape to a compacted shape to an inflated balloon shape upon delivery of positive pressure into the shell without moving the proximal end relative to the distal end thereof,   the shell having the property of retaining the inflated balloon shape upon removal of the positive pressure causing the shell to assume the balloon shape,   apparatus for guiding the exclusion device to a desired location in a human body while the shell is in the compacted shape,   the pressure tube delivering positive pressure to the shell via the pressure port of the pressure tube to expand the shell to the-inflated balloon shape; and   means for disconnecting the pressure tube from the shell,   (b) advancing the shell to a point within the predetermined orifice or lumen within the human body, and   (c) inflating the shell within the orifice or lumen.   
     
     
         19 . The method of claim  8  wherein the positive pressure comprises fluid pressure. 
     
     
         20 . The method of claim  8  wherein the shell comprises a ductile metal. 
     
     
         21 . The method of claim  8  wherein he shell is formed from plastic. 
     
     
         22 . The method of claim  10  which comprises passing the pressure tube and the conduit over a guide wire. 
     
     
         23 . The method of  claim 11  which comprises disconnecting the pressure tube from the shell while simultaneously retaining the shell in position with the pusher tube, 
     
     
         24 . The method of  claim 11  which comprises twisting or tearing the pressure tube to remove the pressure tube from the shell. 
     
     
         25 . The method of claim  1  which comprises pulling the pressure tube proximally while pushing the pusher tube distally to detach the exclusion device from the pressure tube. 
     
     
         26 . The exclusion device of claim  1  wherein the shell has the capability of transitioning from a manufactured shape to a compacted shape to an inflated balloon shape upon delivery of positive pressure into the shell and without moving the proximal end of the shell relative to the distal end thereof.