Exclusion Device and System For Delivery

Abstract

A medical flow restrictor that may be used to exclude a saccular aneurysm from the circulatory system. The device, a thin walled, foil-like shell, is compacted for delivery. The invention includes the device, electroforming fabrication methods, 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. Negative pressure is used to collapse 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 . An exclusion device comprising: 
 a shell comprising at least two lobes separated by a waist, wherein the shell is capable of containing pressure;    a hollow stem connected to one lobe of the shell, wherein the stem communicates fluid pressure to the inside of the shell; and,    wherein the shell is capable of transitioning from a manufactured shape to a compacted cylindrical shape to a pressure-expanded shape to a vacuum pressure-collapsed shape, wherein the vacuum pressure collapse reduces the two lobes to closely-spaced disks.    
   
   
       2 . The device of  claim 1 , wherein a material comprising the shell may be balloon-contoured without regaining a pressure-expanded shape.  
   
   
       3 . The device of  claim 1 , wherein the shell has a thickness of about 3 microns to about 10 microns.  
   
   
       4 . The device of  claim 1 , wherein the shell comprises a ductile, radiopaque material.  
   
   
       5 . The device of  claim 4 , wherein the material is an electroformed metal.  
   
   
       6 . The device of  claim 1 , wherein said shell comprises a material selected from the group consisting of plastic, rubber, metal, a biodegradable material, and combinations thereof.  
   
   
       7 . The device of  claim 1 , further comprising at least two additional lobes in the stem forming bellows for delivery flexibility.  
   
   
       8 . The device of  claim 1 , further comprising an electroplated porous layer deposited on an outer surface of the shell.  
   
   
       9 . The device of  claim 1 , wherein the shell comprises an inner surface that may be activated to bond to itself upon vacuum collapse and balloon contouring of the shell.  
   
   
       10 . The device of  claim 1 , wherein the shell comprises small pores in the range of 5 to 25 microns in diameter.  
   
   
       11 . The device of  claim 10 , wherein the pores are filled with a dissolvable or biodegradable material.  
   
   
       12 . The device of  claim 1 , wherein the shell comprises large pores in the range of 25 to 100 microns in diameter.  
   
   
       13 . The device of  claim 12 , wherein the pores are filled with a dissolvable or biodegradable material.  
   
   
       14 . An endovascular delivery system comprising a delivery tube that communicates pressure between an external device and an exclusion device shell and pushes the shell in a compacted shape through a body lumen.  
   
   
       15 . The endovascular delivery system of  claim 14 , further comprising a guidewire over which the shell is compacted and over which the compacted shell slides.  
   
   
       16 . The endovascular delivery system of  claim 14 , further comprising a catheter tube through which the compacted shell is delivered from outside a body to an endovascular deployment site, and means to disconnect the shell from the delivery tube.  
   
   
       17 . The endovascular delivery system of  claim 16 , wherein the disconnection means comprises a pushed wire inside the delivery tube, the pushed wire having a distal tip adapted to shear the device from the distal tip of the delivery tube.  
   
   
       18 . The endovascular delivery system of  claim 16 , wherein the disconnection means comprises a second tube outside the delivery tube, wherein the second tube has sufficient longitudinal compressive strength to work in conjunction with the delivery tube whereby the second tube is positioned against a proximal surface of the collapsed shell and held in place while the delivery tube is pulled proximately to shear a stem on the shell or a proximal portion of the shell from the shell.  
   
   
       19 . The endovascular delivery system of  claim 14 , further comprising a cylindrical sheath that restrains at least a portion of the shell from expanding until the sheath is pulled proximally to allow a second portion of the shell to be pressure expanded, facilitating the alignment of the shell at a delivery site within a body.  
   
   
       20 . A device for intraluminal use to limit circulation or flow of fluid or other matter through a body orifice or into an aneurysmal sac from the circulatory system, the device comprising: 
 a shell attached to a stem adapted for air tight connection to a delivery tube    wherein the device transitions from a manufactured geometry to a compacted delivery geometry to an expanded geometry at the deployment site, to a final collapsed geometry, and,    wherein the expansion results from internal positive pressure transmitted through a delivery tube communicating between the stem of the device and an external pump, and,    wherein the collapse results from the application of internal negative pressure developed by the pump.    
   
   
       21 . A method of delivering an endovascular exclusion device comprising: 
 attaching an intravascular device to a delivery tube;    compacting the device to a smaller delivery diameter;    advancing the delivery tube to a treatment site within an artery;    applying positive pressure via the delivery tube to expand the intravascular device with a waist used to locate an intravascular device;    applying negative pressure via the delivery tube to collapse the device;    disconnecting the device from the delivery tube; and,    contouring the device to the artery wall to fully open lumen of the artery.    
   
   
       22 . A process for manufacturing an intraluminal device comprising: 
 fabricating a sacrificial mandrel with a surface that will become the inside surface of the device;    attaching an electrical stem extension to the stern of the device;    electroforming a thin metal shell adapted to be a pressure vessel on the mandrel;    cutting the stem extension to expose mandrel material; and,    chemically dissolving the mandrel.