Implant and method for manufacturing
The present invention proposes an implant, in particular an intraluminal endoprosthesis, having a body, comprising at least one at least largely biodegradable metallic material, in particular magnesium or a magnesium alloy. To improve the degradation behavior, the implant has a first layer on at least a portion of its body surface, said layer containing a hydrogen-binding material, preferably palladium. Furthermore, methods for producing such an implant are given.
1. An implant formed as an endovascular stent, having a body forming most of the mechanical integrity of the implant, the body comprising at least one at least largely biodegradable metallic material, optionally magnesium or a magnesium alloy, characterized in that the implant has a first layer comprising a hydrogen-binding material comprising palladium on at least a portion of the body surface; a second layer comprising parylene and/or magnesium stearate arranged over and contacting the first layer on at least a portion of the surface of the implant body, wherein the palladium comprises palladium particles having grain sizes between approximately 20 nm and approximately 15 μm.
2. The implant according to claim 1 , characterized in that the first layer has a layer thickness of approximately 1 μm to approximately 10 μm, optionally approximately 2 μm to approximately 6 μm.
3. The implant according to claim 1 , characterized in that the palladium forms palladium hydride to act as a sacrificial element during degradation of the implant, further wherein the grain sizes are between approximately 50 nm and approximately 500 nm.
4. The implant according to claim 1 , characterized in that the second layer has a layer thickness of approximately 0.5 μm to approximately 10 μm.
5. An implant formed as an endovascular stent, having a body forming most of the mechanical integrity of the implant, the body comprising at least one at least largely biodegradable metallic material, optionally magnesium or a magnesium alloy, characterized in that the implant has a first layer comprising a hydrogen-binding material comprising palladium on at least a portion of its the body surface; a second layer comprising parylene and/or magnesium stearate arranged over and contacting the first layer on at least a portion of the surface of the implant body; and an intermediate layer that is a product of a plasma chemical treatment of the body's biodegradable metallic material and arranged between the surface of the body and the first layer, the intermediate layer being porous and being provided over at least a portion of the body surface of the implant, the thickness of the intermediate layer being approximately 1 μm to approximately 20 μm, optionally approximately 2 μm to approximately 8 μm.
6. The implant according to claim 5 , characterized in that the plasma chemical treatment forms the intermediate layer with at least one compound selected from the group comprising consisting of phosphates, hydroxides, and oxides of the biodegradable metallic material.
7. The implant according to claim 1 , wherein the second layer comprises magnesium stearate.
8. The implant according to claim 6 , wherein the pores comprise bases with sidewalls, further wherein the first layer forms at the bases and the sidewalls of the pores.
9. The implant according to claim 1 , further comprising a porous intermediate layer arranged between the surface of the body and the first layer, wherein the intermediate layer comprises at least one member selected from the group consisting of phosphates, hydroxides and oxides of the biodegradable metallic material, further wherein the intermediate layer is a product of plasma chemical treatment of the body.
10. The implant according to claim 5 , wherein the second layer comprises magnesium stearate.