Graft with bioabsorbable support frame
View Patent ↗The medical devices, such as stent grafts, described herein preferably include a tubular remodelable graft material attached to a support frame formed at least in part from a metallic bioabsorbable material. The remodelable graft material preferably includes an extracellular matrix material such as small intestinal submucosa (SIS). The support frame attached to the graft is preferably a bioabsorbable magnesium alloy. The devices may be implanted within a peripheral vascular body vessel from a percutaneous delivery catheter.
1. A medical device for implantation in a body vessel comprising:
a support frame comprising a core material selected from the group consisting of stainless steel, a cobalt-chromium alloy and a nickel-titanium alloy and a bioabsorbable alloy comprising a first and a second metallic material, where the core material is at least partially enclosed by the bioabsorbable alloy, and
a graft material,
where the support frame attaches to the graft material defining a tubular lumen, where the graft material comprises an extracellular matrix material and where the extracellular matrix material is a remodelable material that induces cellular infiltration and neovascularization.
2. The medical device of claim 1 , wherein the bioabsorbable alloy comprises a material selected from a first group consisting of: magnesium, titanium, zirconium, niobium, tantalum, zinc, and silicon.
3. The medical device of claim 2 , where the bioabsorbable alloy comprises magnesium and about 0.1% to about 2% aluminum.
4. The medical device of claim 3 , where the bioabsorbable alloy further comprises up to about 1% of a rare earth metal.
5. The medical device of claim 1 , wherein the bioabsorbable alloy comprises magnesium and one or more metals.
6. The medical device of claim 5 , wherein the bioabsorbable alloy comprises a first metal selected from a first group consisting of: magnesium, titanium, zirconium, niobium, tantalum, zinc, and silicon; and a second metal selected from the group consisting of: lithium, sodium, potassium, calcium, iron, and manganese.
7. The medical device of claim 5 , wherein the bioabsorbable alloy is selected from the group consisting of: lithium-magnesium, sodium-magnesium, and zinc-titanium.
8. The medical device of claim 5 , wherein the bioabsorbable alloy further comprises gold.
9. The medical device of claim 1 , where the bioabsorbable alloy comprises at least 90% magnesium.
10. The medical device of claim 9 , where the bioabsorbable alloy further comprises between about 3.7% and 5.5% yttrium.
11. The medical device of claim 10 , where the bioabsorbable alloy further comprises between about 1.5% and 4.4% rare earth materials.
12. The medical device of claim 1 , where the bioabsorbable alloy consists of 0.7-4.3% yttrium, 2.4-4.4% rare earth metals, at least 0.4% zirconium and magnesium, the rare earth metals comprising 2.0-2.5% neodymium.
13. The medical device of claim 1 , where the support frame is moveable from a radially compressed configuration to a radially expanded configuration, the medical device having a diameter in the radially expanded state of at least about 4 mm.
14. The medical device of claim 1 , where the support frame has an elastic recoil of about 1-10%.
15. The medical device of claim 1 , where the extracellular matrix material is submucosa.
16. The medical device of claim 1 , where the graft material has a perforated region defining a plurality of holes sized between about 10 microns and 100 microns.
17. The medical device of claim 1 , where the bioabsorbable alloy comprises magnesium and one or more metals selected from the group consisting of: titanium, zirconium, niobium, tantalum, zinc, yttrium, and silicon; and further comprises at least one metal selected from the group consisting of: aluminum, lithium, sodium, potassium, calcium, iron, gold, manganese, lanthanum, cerium, praseodymium, neodymium, promethium, samarium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, and lutetium; where the support frame has an elastic recoil of about 1-10%; and where the graft material comprises an extracellular matrix material and a bioactive agent.
18. The medical device of claim 1 , where the extracellular matrix material comprises perforations.