SELF-SUPPORTING LAMINATED FILMS, STRUCTURAL MATERIALS AND MEDICAL DEVICES MANUFACTURED THEREFROM AND METHODS OF MAKING SAME

• US 20150173885A1
• Filed: 09/30/2014
• Published: 06/25/2015
• Est. Priority Date: 05/12/2000
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Marton, Denes
• Granted Patent: US 10,449,030 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61L 27/047 Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/12 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material

Abstract

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.

Claims

1. An implantable medical graft comprising a tube or film made of a plurality of layers of at least one biocompatible metal material, wherein the plurality of layers form a self-supporting monolithic laminate structure.

2. The implantable medical graft according to claim 1, wherein the biocompatible metal 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.

3. The implantable medical graft according to claim 1, wherein each of the plurality of metal layers have a plurality of openings passing there through.

4. The implantable medical graft according to claim 1, wherein the self-supporting monolithic laminate structure has at least one surface thereof having controlled heterogeneities thereupon.

5. The implantable medical graft according to claim 1, further comprising adjacent structural elements 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.

6. The implantable medical graft according to claim 5, wherein a plurality of openings pass transversely through the interstitial web.

7. The implantable medical graft according to claim 5, wherein the plurality of openings are positioned in a pattern.

8. The implantable medical graft according to claim 5, wherein the plurality of openings are positioned randomly.

9. The implantable medical graft according to claim 5, wherein the plurality of openings permit cellular migration through each opening without permitting fluid flow there through.

10. The implantable medical graft according to claim 7, wherein the pattern of the plurality of openings is an alternating slot pattern in which the plurality of openings are arrayed adjacent one and other forming a y-axis and x-axis oriented array.

11. The implantable medical graft according to claim 5, wherein the film or tube covers the plurality of structural elements and is joined with a terminal portion of the plurality of structural elements.

12. An implantable medical graft comprising an abluminal film composed of biocompatible metal layers and a self-supporting luminal film concentrically positioned within the abluminal film, wherein the self-supporting luminal film is composed of biocompatible metal layers, wherein an interfacial region is defined where the abluminal film and luminal film are in immediate juxtaposition with one another.

13. The implantable medical graft according to claim 12, wherein the biocompatible metal 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.

14. The implantable medical graft according to claim 12, wherein a first plurality of openings are positioned through the abluminal film and a second plurality of openings are positioned through the luminal film.

15. The implantable medical graft according to claim 14, wherein the first and second plurality of openings are positioned out of phase with one another.

16. The implantable medical graft according to claim 14, wherein the size of the plurality of openings in the luminal film are different than the size of the plurality of openings in the abluminal film.

17. The implantable medical graft according to claim 12, wherein the interfacial region has a microroughness with a peak-to-valley depth between about 10μ

to 15μ

.

18. The implantable medical graft according to claim 17, the microroughness spans the surface area region between adjacent pairs of openings.

19. The implantable medical graft according to claim 12, wherein a plurality of spacing members project into the interfacial region maintaining the abluminal and the luminal film in a concentric spaced-apart relationship.

20. The implantable medical graft according to claim 12, further comprising a plurality of microgrooves in an interfacial region surface of at least one of the abluminal or luminal film.