# US 10,945,828 B2 · Self-supporting laminated films, structural materials and medical devices manufactured therefrom and methods of making same

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- Number: US 10,945,828 B2
- Document ID: US10945828B2
- Status: Granted
- Kind: B2
- Application number: 16/569,034
- Filed: 2019-09-12
- Published: 2020-01-02
- Granted: 2021-03-16
- Earliest claimed: 2000-05-12
- Assignees: Vactronix Scientific, LLC
- Applicants: Vactronix Scientific, LLC
- Inventors: Denes Marton
- Web page: https://patentgrep.com/patent/US10945828B2

## CPC

- A61F 2/07: Stent-grafts
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61L 27/047: {Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06}
- A61L 27/06: Titanium or titanium alloys
- A61L 27/40: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L 31/022: {Metals or alloys}
- A61L 31/12: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61F 2002/075: {the stent being loosely attached to the graft material, e.g. by stitching}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2220/005: using adhesives
- A61F 2220/0058: soldered or brazed or welded
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## 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

### Claim 1

An implantable medical material comprising of a self-supporting monolithic structure composed of a plurality of layers of at least one biocompatible metal material;
an interface region between adjacent pairs of the plurality of layers of at least one biocompatible metal material, wherein the interface region further comprises a microroughness in abutting surfaces of each of the adjacent pairs of the plurality of layers of at least one biocompatible metal material; the microroughness having a peak-to-valley depth of between about 5μ to about 65μ and the interface region is characterized by a local concentration of grain boundaries that is higher than a local concentration of grain boundaries within the at least one biocompatible metal material of the plurality of layers;
at least a first layer of the plurality of layers of at least one biocompatible metal material consisting of a radiopaque biocompatible material; and
at least a second layer of the plurality of layers of at least one biocompatible metal material comprising a shape memory metal alloy.

### Claim 2 (depends on 1)

The implantable medical material according to claim 1, wherein the at least one 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.

### Claim 3 (depends on 1)

The implantable medical material according to claim 1, wherein the interface region further comprises a microroughness having a peak-to-valley depth of between 10 μ and 15 μ between adjacent pairs of the plurality of layers.

### Claim 4 (depends on 1)

The implantable medical material according to claim 1, wherein the interface region consists of grain size and grain columnar morphology that extend perpendicular to the plane of each of the adjacent pairs of the plurality of layers.

### Claim 5 (depends on 1)

The implantable medical material according to claim 1, wherein the microroughness spans the interface region between adjacent layers.

### Claim 6 (depends on 1)

The implantable medical material according to claim 1, wherein the microroughness is randomly oriented.

### Claim 7 (depends on 1)

The implantable medical material according to claim 1, wherein the microroughness is selectively oriented.

### Claim 8 (depends on 7)

The implantable medical material according to claim 7, wherein the microroughness is helically or circumferentially oriented about the interface region.

### Claim 9

An implantable medical device, comprising a self-supporting monolithic structure having a plurality of layers of at least one biocompatible metal material, at least one of the plurality of layers consisting of a radiopaque biocompatible metal material and an interface region defined at a boundary between adjacent pairs of the plurality of layers, the interface region having a local concentration of grain boundaries that is higher than a local concentration of grain boundaries within the remainder of the at least one biocompatible metal material of the plurality of layers, and wherein the interface region further comprises a microroughness having a peak-to-valley depth of between about 5 μm to about 65 μm between adjacent pairs of the plurality of layers.

### Claim 10 (depends on 9)

The implantable medical device according to claim 9, wherein the at least one 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.

### Claim 11 (depends on 9)

The implantable medical device according to claim 9, wherein the interface region further comprises a grain structure microroughness having a peak-to-valley depth of between 10 μ and 15 μ.

### Claim 12 (depends on 9)

The implantable medical device according to claim 9, wherein the interface region consists of grain size and grain columnar morphology that extend perpendicular to the plane of each of the adjacent pairs of the plurality of layers.

### Claim 13 (depends on 9)

The implantable medical device according to claim 9, wherein the microroughness spans the interface region between adjacent layers.

### Claim 14 (depends on 9)

The implantable medical device according to claim 9, wherein the mircroroughness is randomly oriented.

### Claim 15 (depends on 9)

The implantable medical device according to claim 9, wherein the microroughness is selectively oriented.

### Claim 16 (depends on 15)

The implantable medical device according to claim 15, wherein the microroughness is helically or circumferentially oriented about the interface region.