THIN-FILM MICROMESH MEDICAL DEVICES AND RELATED METHODS

• US 20170265870A1
• Filed: 06/06/2017
• Published: 09/21/2017
• Est. Priority Date: 07/02/2015
• Status: Active Grant

• Current Assignee: Monarch Biosciences, Inc.
• Original Assignee: Nsvascular, Inc.
• Inventors: Kealey, Colin, Cook, Ian A., Gupta, Vikas
• Granted Patent: US 11,399,841 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/067 modular
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/3006 Properties of materials and coating materials
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/3695 characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Thin-film mesh for medical devices, including stent and scaffold devices, and related methods are provided. Micropatterned thin-film mesh, such as thin-film Nitinol (TFN) mesh, may be fabricated via sputter deposition on a micropatterned wafer. The thin-film mesh may include slits to be expanded into pores, and the expanded thin-film mesh used as a cover for a stent device. The stent device may include two stent modules that may be implanted at a bifurcated aneurysm such that one module passes through a medial surface of the other module. The thin-film mesh may include pores with complex, fractal, or fractal-like shapes. The thin-film mesh may be used as a scaffold for a scaffold device. The thin-film scaffold may be placed in a solution including structural protein such as fibrin, seeded with cells, and placed in the body to replace or repair tissue.

Claims

1. A method comprising:

forming a metallic thin film on a substrate by sputter deposition;

forming fenestrations in the metallic thin film based on micropatterns provided on the substrate;

placing the metallic thin film in a solution to form structural proteins on the metallic thin film.

2. The method of claim 1, further comprising expanding the metallic thin film to open up the fenestrations, such that the metallic thin film has a pore density of between 65 and 1075 pores per mm² and a percent area coverage of between 16 and 66%;

3. The method of claim 1, wherein the fenestrations form a fractal-like micropattern.

4. The method of claim 1, further comprising adding one or more small molecules or large molecules to the metallic thin film or the structural proteins configured to achieve a desired therapeutic effect at an anatomic site of interest where the metallic thin film is to be deployed.

5. The method of claim 1, further comprising:

deep reactive ion etching a micropattern of trenches on a surface of the substrate, the trenches corresponding to the fenestrations of the metallic thin-film;

depositing a lift-off layer on the etched substrate;

depositing a first Nitinol layer over the lift-off layer; and

etching the lift-off layer to form the metallic thin film.

6. The method of claim 5, further comprising:

depositing a bonding layer on at least one area of the first Nitinol layer;

depositing a sacrificial layer on a remaining area of the first Nitinol layer;

depositing a second Nitinol layer on the bonding layer and the sacrificial layer; and

annealing the first Nitinol layer and the second Nitinol layer with the bonding layer;

wherein the etching further etches the sacrificial layer to form a three-dimensional, metallic thin film micromesh.

7. The method of claim 1, further comprising:

forming a plurality of metallic thin films;

placing the plurality of metallic thin films in one or more solutions to form structural proteins on the plurality of metallic thin films; and

stacking the plurality of metallic thin films to form a three-dimensional thin-film micromesh structure.

8. The method of claim 1, further comprising:

forming a plurality of metallic thin films;

forming an inner and an outer thin-film mesh cylinders from the plurality of metallic thin films;

placing the inner and the outer thin-film mesh cylinders in one or more solutions to form structural proteins on the inner and the outer thin-film mesh cylinders; and

enclosing the inner thin-film mesh cylinder in the outer thin-film mesh cylinder to form a multi-layer thin-film mesh cylinder structure.

9. The method of claim 1, further comprising:

seeding the metallic thin film with cells; and

incubating the metallic thin film to promote cell growth.

10. The method of claim 1, further comprising:

placing the metallic thin film over a backbone to form a cylindrical tube; and

attaching the metallic thin film to the backbone.

11. A thin-film micromesh device comprising:

a metallic thin film formed from sputter deposition on a substrate, the metallic thin film including a plurality of fenestrations; and

structural proteins formed on the metallic thin film.

12. The thin-film micromesh device of claim 11, wherein the metallic thin film or the structural proteins comprise one or more small molecules or large molecules configured to achieve a desired therapeutic effect at an anatomic site of interest where the thin film micromesh device is to be deployed.

13. The thin-film micromesh device of claim 11, wherein the metallic thin film has a pore density of between 65 and 1075 pores per mm² and a percent area coverage of between 16 and 66 when the metallic thin film is expanded to open up the plurality of fenestrations.

14. The thin-film micromesh device of claim 11, wherein the plurality of fenestrations form a fractal-like micropattern.

15. The thin-film micromesh device of claim 11, wherein the fenestrations form one or more of a honeycomb pattern, an equilateral-triangle pattern, and an overlapping-circle pattern.

16. The thin-film micromesh device of claim 11, wherein the metallic thin film comprises thin-film Nitinol (TFN).

17. The thin-film micromesh device of claim 11, further comprising a plurality of metallic thin films each provided with structural proteins, wherein the plurality of metallic thin films are stacked together to form a three-dimensional thin-film micromesh structure.

18. The thin-film micromesh device of claim 11, further comprising an outer thin-film mesh cylinder enclosing an inner thin-film mesh cylinder, wherein each of the inner and the outer thin-film mesh cylinders is provided with structural proteins.

19. The thin-film micromesh device of claim 11, further comprising a seeded cell layer on the metallic thin film incubated to promote cell growth.

20. The thin-film micromesh device of claim 11, further comprising a bioabsorbable backbone on which the metallic thin film is assembled, wherein the bioabsorbable backbone is configured to be absorbed after implantation in a patient for a predetermined amount of time.