Over-the-wire exclusion device and system for delivery
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. An exclusion device comprising:
a shell comprising a proximal hollow stem, and a distal hollow stem and at least two lobes separated by a waist, wherein the waist is narrower than the at least two lobes, and wherein the shell is capable of containing pressure;
a pressure tube comprising a pressure port, wherein the distal hollow stem of the shell is attached to a distal tip of the pressure tube and wherein the pressure port communicates pressure to the inside of the shell;
a pusher tube; and
a guidewire, wherein the guidewire is in contact with an inner diameter of the distal tip of the pressure tube in which the shell in the compacted shape is delivered to an endovascular deployment site;
wherein the shell is capable of transitioning from a manufactured shape to a compacted shape to a pressure-expanded shape to a mechanically collapsed shape,
wherein the mechanically collapsed shape is formed when the shell is collapsed reducing the at least two lobes to at least two closely-spaced disks as a result of the convergence of the distal tip of the pressure tube and the distal tip of the pusher tube as the pressure tube is pulled proximally and the pusher tube is pushed distally and wherein the distal hollow stem of the shell and the distal tip of the pressure tube are disconnected by continuing the convergence until the force generated tears the pressure tube from the at least two closely-spaced disks.
2. The device of claim 1 , wherein the shell is formed from a ductile metal capable of maintaining a shape after a shaping force is removed.
3. The device of claim 1 , wherein the shell has a thickness of about 3 microns to about 20 microns.
4. The device of claim 1 , wherein the shell is formed from an electroformed metal.
5. The device of claim 1 , further comprising at least two additional lobes in the proximal hollow stem forming bellows for delivery flexibility.
6. The device of claim 1 , further comprising an electroplated porous layer deposited on an outer surface of the shell.
7. The device of claim 1 , wherein the shell further comprises small pores in the range of 5 to 25 microns in diameter.
8. The device of claim 7 , wherein the small pores are filled with a material selected from the group consisting of a dissolvable material, a biodegradable material and combinations thereof.
9. The device of claim 1 , wherein the shell comprises large pores in the range of 25 to 100 microns in diameter wherein the pores are filled with a material selected from the group consisting of a dissolvable material a biodegradable material and a combination thereof.
10. The device of claim 1 , wherein the pressure tube communicates pressure between the proximal end of the pressure tube and the interior volume of the aneurysm for the removal of fluid.
11. The device of claim 1 , further comprising a material selected from a therapeutic agent, at least one embolic coil, an embolic agent and combinations thereof,
wherein the material is injected through the pressure tube into an aneurismal sac at an endovascular deployment site.
12. The device of claim 1 , further comprising a protective sheath to cover the shell in the compacted shape for delivery to an endovascular deployment site.
13. The device of claim 1 wherein the shell is formed from plastic and wherein an inner surface of the shell is activated, after expansion in the body, with a solvent or other liquid to make the inner surface of the shell tacky so that it sticks to itself to hold the final shape.
14. The device of claim 1 that is capable of balloon contouring after detachment.