Self-supporting laminated films, structural materials and medical devices manufactured therefrom and method of making same

• US 20010032013A1
• Filed: 05/11/2001
• Published: 10/18/2001
• Est. Priority Date: 11/19/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Marton, Denes
• Granted Patent: US 6,849,085 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 31/12 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. 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.

Claims

1. An implantable medical device comprising a self-supporting structural member fabricated of a plurality of laminated layers of at least one biocompatible material.

2. The implantable medical device according to

claim 1

, wherein at least one of the plurality of laminated layers further comprises a monolithic bulk material.

3. The implantable medical device according to

claim 1

, wherein the self-supporting structural member further comprises a stent having a plurality of structural elements.

4. The implantable medical device according to

claim 1

, wherein the self-supporting structural member further comprises a graft.

5. The implantable medical device according to

claim 1

, wherein the self-supporting structural member further comprises a stent-graft.

6. The implantable medical device according to

claim 1

, wherein the self-supporting structural member further comprises a planar film.

7. The implantable 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.

8. The implantable medical device according to

claim 3

, wherein at least some of the plurality of structural elements further comprise laminated layers of a biocompatible materials 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.

9. The implantable medical device according to

claim 4

, wherein the graft further comprises a tubular member having a plurality of laminated layers concentrically adjacent to one another, each of the plurality of laminated layers having a plurality of openings passing therethrough of sufficient dimension to permit cellular migration therethrough without permitting fluid flow therethrough.

10. The implantable medical device according to

claim 5

, wherein the stent-graft further comprises a tubular member comprising stent regions and graft regions.

11. The implantable medical device according to

claim 10

, wherein the stent regions further comprises a plurality of structural members each structural member being comprised of a plurality of laminated layers of a biocompatible material and the graft regions further comprise at least one of the plurality of laminated layers of the biocompatible material forming the structural members of the stent regions.

12. The implantable medical device according to

claim 11

, wherein the graft regions subtend interstitial spaces between adjacent pairs of the plurality of structural members.

13. The implantable medical device according to

claim 12

, wherein the stent regions further comprise a luminal surface, an abluminal surface and a z-axis thickness and the graft regions have a z-axis thickness less than the stent region z-axis thickness.

14. The implantable medical device according to

claim 5

, stent-graft further comprises a stent comprising a plurality of interconnected structural elements forming a generally tubular member having a luminal surface, an abluminal surface, a proximal end and a distal end, and a graft comprising a film projecting outwardly from at least one of the proximal end and the distal end of the stent and along a longitudinal axis of the stent.

15. The implantable medical device according to

claim 14

, wherein the film is everted from the at least one of the proximal end and the distal end of the stent over one of the luminal surface and the abluminal surface of the stent and joined to an opposing one of the proximal end and the distal end from which the graft projects.

16. An implantable medical graft comprising at least two tubular members concentrically positioned with respect to one another thereby defining an interfacial region between the at least two tubular members, each of the tubular members being comprised of a plurality of laminated plies forming the 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.

17. The implantable medical graft according to

claim 16

, further comprising a plurality of spacing members projecting into the interfacial region thereby maintaining the at least two tubular members in a concentric spaced-apart relationship.

18. The implantable medical graft according to

claim 16

, further comprising a plurality of microgrooves in an interfacial region surface of at least one of the at least two tubular members.

19. An endoluminal stent comprising a plurality of structural members positioned to define a generally tubular member having interstitial regions between adjacent structural members, at least some of the plurality of structural members comprising a plurality of laminated plies of a biocompatible material and a web of a biocompatible material subtending at least a portion of some of the interstitial regions.

20. The endoluminal stent according to

claim 19

, further comprising a plurality of openings passing through the web, the plurality of openings being sized to permit migration of cellular and sub-cellular matter therethrough.