Self-supporting laminated films, structural materials and medical devices manufactured therefrom and methods of making same
View Patent ↗Metal foils, wires, and seamless tubes with increased mechanical strength are provided. As opposed to wrought materials that are made of a single metal or alloy, these materials are made of two or more layers forming a laminate structure. Laminate structures are known to increase mechanical strength of sheet materials such as wood and paper products and are used in the area of thin films to increase film hardness, as well as toughness. Laminate metal foils have not been used or developed because the standard metal forming technologies, such as rolling and extrusion, for example, do not lend themselves to the production of laminate structures. Vacuum deposition technologies can be developed to yield laminate metal structures with improved mechanical properties. In addition, laminate structures can be designed to provide special qualities by including layers that have special properties such as superelasticity, shape memory, radio-opacity, corrosion resistance etc. Examples of articles which may be made by the inventive laminate structures include implantable medical devices that are fabricated from the laminated deposited films and which present a blood or body fluid and tissue contact surface that has controlled heterogeneities in material constitution. An endoluminal stent-graft and web-stent that is made of a laminated film material deposited and etched into regions of structural members and web regions subtending interstitial regions between the structural members. An endoluminal graft is also provided which is made of a biocompatible metal or metal-like material. The endoluminal stent-graft is characterized by having controlled heterogeneities in the stent material along the blood flow surface of the stent and the method of fabricating the stent using vacuum deposition methods.
1. A medical device comprising a tubular self-supporting laminated structural member composed of metal films, foils, wires, or seamless tubes, the tubular self-supporting laminated structural member having a first layer of a first metal biocompatible material having a luminal surface disposed entirely within an abluminal surface of the first layer and a second layer of a second metal biocompatible material integral with and extending radially from a fractional region of the abluminal surface of the first layer, wherein the second layer of the second metal biocompatible material defines a plurality of structural members, the structural members defining open regions therebetween in the second layer, and the first layer of the first metal biocompatible material subtends substantially all of the open regions between adjacent pairs of the plurality of structural members in the second layer.
2. The medical device according to claim 1 wherein the first and second metal layers comprise a monolithic bulk material.
3. The medical device according to claim 2 wherein the monolithic bulk material is selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloys, nitinol, and stainless steel.
4. The medical device according to claim 1 , wherein the self-supporting laminated structural member further comprises one of a stent, a graft and a stent-graft.
5. The medical device according to claim 1 , wherein the self-supporting laminated structural member has at least one surface thereof having controlled heterogeneities thereupon.
6. An implantable medical device comprising a substantially monolithic tubular self-supporting laminated member composed of metal films, foils, wires, or seamless tubes, the substantially monolithic tubular self-supporting laminated member having a plurality of integral biocompatible metal layers arranged such that each of the plurality of integral biocompatible metal layers includes an abluminal surface and a luminal surface disposed entirely within the abluminal surface and one or more of the plurality of integral biocompatible metal layers fractionally overlaps with a rest of the plurality of integral biocompatible metal layers wherein regions of overlap have a first thickness and regions of non-overlap have a second thickness and extend entirely between the regions of overlap, wherein the first thickness is greater than the second thickness and wherein a plurality of openings is disposed through only the regions of non-overlap, each of the openings dimensioned to permit cellular migration through the opening without permitting blood leakage or seepage through the opening.
7. The implantable medical device according to claim 6 wherein the regions of overlap define a plurality of open regions and the regions of non-overlap define webs subtending at least a portion of some of the open regions.
8. The medical device according to claim 7 , further comprising a second plurality of openings disposed through the webs.
9. The implantable medical device according to claim 8 , wherein at least one of the plurality of integral biocompatible metal layers is selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold silicon magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum nitinol, and stainless steel.
10. The medical device according to claim 7 , wherein the regions of overlap further comprise a plurality of structural members positioned to define a generally tubular member further comprising a stent component and the webs further comprising a graft component.