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 graft comprising a tubular film of a biocompatible metal material, the tubular film further comprising plural metal layers of at least one biocompatible metal material formed into a substantially monolithic structure, the tubular film including a plurality of structural elements, wherein adjacent structural elements are spaced apart defining a plurality of interstitial regions therebetween and subtended by a plurality of interstitial webs integral with the plurality of structural elements to subtend the interstitial regions, wherein a plurality of openings transversely pass through the interstitial webs and the openings include a size to permit cellular migration without permitting fluid flow therethrough, wherein a tubular member covers the plurality of structural elements and is joined with a terminal portion of the plurality of structural elements, wherein the tubular member includes a plurality metal layers concentrically adjacent to one another, and each of the plurality of metal layers having the plurality of openings passing therethrough.
2. The medical graft according to claim 1 , at least some of the plurality of structural elements being fabricated of plural metal layers of at least one biocompatible material and formed into a substantially monolithic structure.
3. The medical graft according to claim 1 , wherein at least one of the plural metal layers further comprises a monolithic bulk material.
4. The medical graft according to claim 3 , 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.
5. The medical graft according to claim 4 , further comprising structural region in the film of a biocompatible metal or metal-like material having a thickness greater than a thickness of the film, the structural regions being substantially monolithic with the film.
6. The medical graft according to claim 1 , wherein the plurality of openings passing therethrough include a diameter of about 19 μm.
7. The medical graft according to claim 1 , wherein the plurality of openings in each concentrically adjacent metal layer are positioned out of phase with one another.
8. The medical graft according to claim 1 , wherein at least some of the plurality of openings in at least some of the plural metal layers are positioned in phase with one another.
9. An implantable medical graft comprising at least two tubular members concentrically positioned and in immediate juxtaposition with respect to one another throughout the entire longitudinal length of the tubular members thereby defining an interfacial region between the at least two tubular members, each of the tubular members being formed of biocompatible metal and comprised of plural metal layers forming each tubular member, and a plurality of micro-openings passing through a wall thickness of each tubular member that create cellular migration pathways between a luminal and an abluminal surface of each of the at least two tubular members and through the graft, wherein at least a first tubular member defines a plurality of structural members, the structural members defining the perimeters of interstitial regions therebetween, and at least a second tubular member subtends the entirety of the interstitial regions of the first tubular member.
10. The implantable medical graft according to claim 9 , wherein at least one of the tubular members comprises a plurality of spacing members projecting into the interfacial region thereby maintaining the at least two tubular members in a concentric spaced-apart relationship.
11. The implantable medical graft according to claim 9 , further comprising a plurality of microgrooves in an interfacial region surface of at least one of the at least two tubular members.
12. The implantable medical graft according to claim 9 , wherein the biocompatible metal 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.
13. An implantable medical graft comprising at least two tubular members concentrically positioned with respect to one another throughout the entire longitudinal length of the tubular members thereby defining an interfacial region between the at least two tubular members, wherein one tubular member is an outer tubular member and another tubular member is an inner tubular member including a plurality of structural elements, wherein adjacent structural elements are spaced apart defining the perimeters of interstitial regions therebetween, wherein the interstitial regions are subtended by a plurality of interstitial webs integral with the plurality of structural elements, and each tubular member formed from a biocompatible metal and comprised of a plural metal layers, wherein the interfacial region includes a microroughness including a peak to valley depth of between about 10 μm to 15 μm.
14. The implantable medical graft according to claim 13 , wherein the biocompatible metal 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.
15. The implantable medical graft according to claim 13 , wherein the outer tubular member includes a plurality of openings having a larger size than a plurality of openings in the inner tubular member to maintain an out-of-phase relationship between the openings of the outer tubular member and the openings of the inner tubular member.
16. The implantable medical graft according to claim 13 , wherein the interfacial region is an annular open region positioned intermediate the two tubular members, wherein the annular open region includes a plurality of microprojections that project radially inward from the luminal surface of the outer tubular member or radially outward from the abluminal surface of the inner tubular member.
17. The implantable medical graft according to claim 13 , wherein the plurality of openings include a diameter between about 5 and 100 μm.
18. An implantable medical graft comprising a tubular self-supporting 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 the first layer including a plurality of structural elements, wherein adjacent structural elements are spaced apart defining the perimeters of interstitial regions therebetween and subtended by a plurality of interstitial webs integral with the plurality of structural elements to subtend the interstitial regions, 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.