Exclusion Device and System For Delivery
First Claim
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.
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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.
209 Citations
22 Claims
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1. An exclusion device comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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- 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.
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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:
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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.
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21. A method of delivering an endovascular exclusion device comprising:
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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.
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22. A process for manufacturing an intraluminal device comprising:
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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.
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Specification