Emboli guarding device
A device including a stent structure or frame to which a sheet is attached for use in minimizing or preventing emboli, particles. and/or air bubbles from migrating into certain areas of the anatomy. The device can be placed in the blood stream in an area of the heart, such as the aortic arch, to direct particles toward the descending aorta rather than toward the brain. The sheet of the device can be a thin film material, which may include multiple fenestrations that are smaller in size than the particles that are to be filtered.
1. A device for directing particle flow in a bloodstream, the device comprising:
a frame extending between an inflow end and an outflow end having a semi-circular cross-section, the frame having a vessel anchoring portion and an internal fluid passageway extending between the inflow and outflow ends; and
a filtering sheet affixed to the frame and extending across a diameter of the outflow end of the frame.
2. The device of claim 1 , wherein the frame includes at least one linear portion and at least one curved portion, such that a plane of the at least one linear portion extends through an interior area of the vessel anchoring portion.
3. The device of claim 1 , wherein the filtering sheet comprises a thin film material comprising multiple fenestrations extending through its thickness.
4. The device of claim 3 , wherein the size of the fenestrations are selected to prevent particles in the bloodstream that are larger than the fenestrations from moving through the filtering sheet from the internal fluid passageway of the frame.
5. The device of claim 1 , wherein the filtering sheet comprises a sheet of pericardial material.
6. The device of claim 1 , wherein the frame is configured to match the shape of a portion of an aortic arch of a patient.
7. The device of claim 1 , wherein the frame is compressible and expandable.
8. The device of claim 7 , wherein the frame comprises a self-expanding material.
9. The device of claim 7 , wherein the frame comprises a material that is expandable with the application of an outward radial force.
10. The device of claim 1 , wherein the internal fluid passageway has an outer periphery that is defined by the frame and the filtering sheet, wherein the frame extends around a first portion of the outer periphery of the fluid passageway and the filtering sheet extends around a second portion of the outer periphery of the fluid passageway.
11. The device of claim 10 , wherein the filtering sheet extends along only a portion of the length of the frame.
12. A method of percutaneously delivering a device to an aortic arch of a patient, the method comprising the steps of:
providing a device comprising a frame extending between an inflow end and an outflow end having a semi-circular cross-section, the frame having a vessel anchoring portion and an internal fluid passageway extending between the inflow and outflow ends, and a filtering sheet affixed to the frame and extending across a diameter of the outflow end of the frame;
compressing the device;
loading the device on a delivery system;
percutaneously delivering the device to the aortic arch with the delivery system; and
expanding the device within the aortic arch.
13. The method of claim 12 , wherein the filtering sheet comprises a thin film material with multiple fenestrations extending through its thickness, wherein the size of the fenestrations are selected to prevent particles in the bloodstream that are larger than a predetermined size from moving through the filtering sheet from the internal fluid passageway.
14. The method of claim 12 , wherein the step of delivering the device comprises positioning the device within the aortic arch so that the filtering sheet is positioned adjacent to the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery.
15. The method of claim 12 , wherein the step of expanding the device within the aortic arch comprises the step of removing an external compressive force from the frame.
16. The method of claim 12 , wherein the step of expanding the device within the aortic arch comprises the step of applying a radial outward force to the frame.