Process of making a prosthetic device from electrospun fibers

• US 8,262,979 B2
• Filed: 08/09/2010
• Issued: 09/11/2012
• Est. Priority Date: 08/07/2009
• Status: Active Grant

• Current Assignee: Zeus Co. LLC
• Original Assignee: Zeus Industrial Products, Inc.
• Inventors: Anneaux, Bruce L., Ballard, Robert L.
• Primary Examiner(s): Tentoni, Leo B
• Application Number:
  US12/852,993
• Publication Number:
  US 20110030885A1
• Time in Patent Office: 764 Days
• Field of Search: 264/236, 264/250, 264/255, 264/257, 264/258, 264/464, 264/465, 264/466, 264/484
• US Class Current: 264/465
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: B01D 2239/025 comprising nanofibres apparatus incorporating such gas filtering material see B01D46/546
• CPC Class Codes: B01D 2239/0631 Electro-spun
• CPC Class Codes: B01D 39/1623 of synthetic origin
• CPC Class Codes: B32B 1/08 : Tubular products
• CPC Class Codes: B32B 2250/03 : 3 layers
• CPC Class Codes: B32B 2250/20 : All layers being fibrous or filamentary
• CPC Class Codes: B32B 2250/242 : All polymers belonging to those covered by group B32B27/32
• CPC Class Codes: B32B 2262/0253 : Polyolefin fibres vinyl or acrylic copolymers B32B2262/0223 or B32B2262/0246
• CPC Class Codes: B32B 2266/025 : Polyolefin vinyl or acrylic copolymers B32B2266/0221, B32B2266/0242
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/322 : comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: B32B 5/022 : Non-woven fabric
• CPC Class Codes: B32B 5/18 : characterised by features of a layer of foamed material
• CPC Class Codes: B32B 5/26 : another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: B32B 7/04 : Interconnection of layers
• CPC Class Codes: B82Y 5/00 : Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
• CPC Class Codes: C08L 27/18 : Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 71/02 : Polyalkylene oxides
• CPC Class Codes: D01D 5/003 : the material being a polymer solution or dispersion D01D5/0053 takes precedence
• CPC Class Codes: D01D 5/0038 : the fibre formed by solvent evaporation, i.e. dry electro-spinning
• CPC Class Codes: D01D 5/0076 : characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid D01D5/0046 takes precedence
• CPC Class Codes: D01D 5/0084 : Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses
• CPC Class Codes: D01D 5/06 : Wet spinning methods D01D5/0046 takes precedence
• CPC Class Codes: D01F 6/12 : from polymers of fluorinated hydrocarbons
• CPC Class Codes: D04H 1/492 : by fluid jet D04H1/49 takes precedence
• CPC Class Codes: D04H 1/54 : by welding together the fibres, e.g. by partially melting or dissolving in combination with needling D04H1/485
• CPC Class Codes: D04H 1/728 : by electro-spinning electro-spinning methods and apparatus D01D5/0007
• CPC Class Codes: D10B 2321/042 : polymers of fluorinated hydrocarbons, e.g. polytetrafluoroethene [PTFE]
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents
• CPC Class Codes: F16L 11/12 : with arrangements for particular purposes, e.g. specially profiled, with protecting layer, heated, electrically conducting F16L11/11 takes precedence
• CPC Class Codes: Y10T 428/31544 : Addition polymer is perhalogenated
• CPC Class Codes: Y10T 442/66 : Additional nonwoven fabric is a spun-bonded fabric
• CPC Class Codes: Y10T 442/677 : Fluorinated olefin polymer or copolymer sheet or film [e.g., TeflonR, etc.]

Abstract

In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

Claims

1. A process of forming a prosthetic device comprising:

forming a dispersion of polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs;

positioning a tubular frame over a tubular polymeric structure;

electrospinning nanofibers from the dispersion onto the tubular frame to form a prosthetic device; and

heating the prosthetic device.

2. The process of claim 1, wherein the polymeric particles comprise polytetrafluoroethylene.

3. The process of claim 2, wherein the dispersion comprises about 50-80 weight percent of polytetrafluoroethylene.

4. The process of claim 1, further comprising sintering.

5. The process of claim 1, wherein the solvent comprises water.

6. The process of claim 1, wherein the fiberizing polymer comprises polyethylene oxide.

7. The process of claim 1, wherein the tubular polymeric structure comprises expanded polytetrafluoroethylene.

8. A process for forming a prosthetic device comprising:

forming a dispersion of polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs;

electrospinning nanofibers from the dispersion onto a tubular polymeric structure;

wrapping a layer of polymeric material over the nanofibers and around the tubular polymeric structure to form a prosthetic device; and

heating the prosthetic device.

9. The process of claim 8, wherein the nanofibers comprise polytetrafluoroethylene.

10. The process of claim 9, wherein the dispersion comprises about 50-80 weight percent of polytetrafluoroethylene.

11. The process of claim 8, further comprising sintering.

12. The process of claim 8, wherein the solvent comprises water.

13. The process of claim 8, wherein the fiberizing polymer comprises polyethylene oxide.

14. The process of claim 8, wherein the tubular polymeric structure comprises expanded polytetrafluoroethylene.

15. The process of claim 8, wherein the layer of polymeric material comprises expanded polytetrafluoroethylene.

16. A process of forming a prosthetic device comprising:

forming a dispersion of polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs;

positioning a tubular frame over a tubular polymeric structure;

electrospinning nanofibers from the dispersion onto the tubular frame;

wrapping a layer of polymeric material over the nanofibers and around the tubular frame and tubular polymeric structure to form a prosthetic device; and

heating the prosthetic device.

17. The process of claim 16, wherein the polymeric particles comprise polytetrafluoroethylene.

18. The process of claim 16, wherein the tubular polymeric structure comprises expanded polytetrafluoroethylene.

19. The process of claim 16, wherein the layer of polymeric material comprises expanded polytetrafluoroethylene.

20. The process of claim 16, wherein the fiberizing polymer comprises a polyacrylamide, polyvinyl alcohol, polyvinylpyrrolidone, dextran, alginate, chitosan, guar gum compound, starch, cellulosic compound, polyacrylate, polycarboxylate, polylactic acid, polymethacrylic acid, or combinations thereof.

21. A process of forming a prosthetic device comprising:

electrostatically spinning nanofibers from a dispersion onto a tubular frame positioned over a tubular polymeric structure to form a prosthetic device, wherein the dispersion comprises polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs; and

heating the prosthetic device.

22. A process of forming a prosthetic device comprising:

electrostatically spinning nanofibers from a dispersion onto a tubular polymeric structure, wherein the dispersion comprises polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs;

wrapping a layer of polymeric material over the nanofibers and around the tubular polymeric structure to form a prosthetic device; and

heating the prosthetic device.

23. A process of forming a prosthetic device comprising:

electrostatically spinning nanofibers from a dispersion onto a tubular frame positioned over a tubular polymeric structure, wherein the dispersion comprises polymeric particles, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs;

wrapping a layer of polymeric material over the nanofibers and around the tubular frame and tubular polymeric structure to form a prosthetic device; and

heating the prosthetic device.