Graft devices and methods of use
A tubular graft device is provided comprising a tubular member and a fiber matrix of one or more polymers about a circumference of the tubular member. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a harvested saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided is method of preparing a tubular graft and connecting the graft between a first body space and a second body space, such as the aorta and a location on an occluded coronary artery, distal to the occlusion.
1. A graft device for a mammalian patient, the graft device comprising:
a tubular member having a wall surrounding a lumen, the wall having an outer surface comprising a series of non-circular cross-sections varying at least in part over a portion of a length of the tubular member;
a deposition coating of polymer fibers deposited onto, formed along, and conforming to the outer surface of the tubular member, the deposition forming a restrictive fiber matrix having an inner circumferential surface substantially contiguous with the series of non-circular cross-sections of the outer surface of the tubular member, over the portion of the length of the tubular member over which the restrictive fiber matrix is coated; and
at least one of a reinforced portion or an anastomotic connector located at at least one of the first end or the second end.
2. The device of claim 1 , wherein the device does not include any metal or magnetic component.
3. The device of claim 1 , wherein the first end or the second end is configured to be cut off in surgery.
4. The device of claim 1 , wherein the at least one reinforced portion comprises a modification of the fiber matrix.
5. The device of claim 4 , wherein the modification comprises an increase in fiber matrix thickness.
6. The device of claim 4 , wherein the fiber matrix comprises a first material and wherein the modification comprises a second material included in the fiber matrix within the reinforced portion.
7. The device of claim 1 , wherein the at least one reinforced portion comprises a reinforcing element.
8. The device of claim 7 , wherein the reinforcing element comprises a band.
9. The device of claim 8 , wherein the band comprises at least a portion selected from a group consisting of: a resiliently biased portion, a plastically deformable portion, or any combination thereof.
10. The device of claim 1 , wherein the at least one reinforced portion is constructed and arranged to biodegrade.
11. The device of claim 1 , wherein the tubular member comprises a patient harvested conduit.
12. The device of claim 11 , wherein the patient harvested conduit comprises a conduit selected from the group consisting of vein; artery; urethra; intestine; esophagus; ureter; trachea; bronchi; duct; fallopian tube; or any combinations thereof.
13. The device of claim 11 , wherein the tubular member comprises a portion of a saphenous vein.
14. The device of claim 1 , wherein the tubular member comprises an artificial conduit.
15. The device of claim 1 , wherein the tubular member comprises a tissue engineered structure or organ.
16. The device of claim 1 , wherein the fiber matrix comprises a diameter that increases as it approaches the first end.
17. The device of claim 16 , wherein the increasing fiber matrix diameter is constructed and arranged to permit expansion of the tubular member at the first end without expanding the fiber matrix.
18. The device of claim 1 , wherein the fiber matrix comprises an average pore size between about 10 microns and about 1,000 microns.
19. The device of claim 18 , wherein the fiber matrix has an average pore size between about 100 microns and about 500 microns.
20. The device of claim 1 , wherein the fiber matrix comprises a porosity between about 50% and about 95%.
21. The device of claim 20 , wherein the fiber matrix comprises a porosity between about 60% and about 95%.
22. The device of claim 1 , wherein the fiber matrix comprises an anisotropic portion.
23. The device of claim 1 , wherein the device comprises an anastomotic connector and wherein the anastomotic connector includes one or more axial projections.
24. The device of claim 23 , wherein the at least one axial projection resides between the tubular member and the fiber matrix.
25. The device of claim 23 , wherein the axial projection resides within the fiber matrix.
26. The device of claim 1 , wherein the at least one of the reinforced portion or the anastomotic connector includes at least one of an increased thickness fiber matrix portion, a decreased thickness fiber matrix portion, a flared fiber matrix portion, a second fiber matrix comprising a different material than the first fiber matrix, a hook and loop component at the first end of the device, an adhesive surface, a second fiber in the fiber matrix, or a magnetic component.
27. The device of claim 1 further comprising an adhesive layer between at least a portion of the fiber matrix and the tubular member.