Prosthetic device including electrostatically spun fibrous layer and method for making the same

• US 9,034,031 B2
• Filed: 08/02/2012
• Issued: 05/19/2015
• 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): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US13/564,927
• Publication Number:
  US 20130053948A1
• Time in Patent Office: 1,020 Days
• Field of Search: 623 111- 154
• US Class Current: 623/1.42
• 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 nanofibers, 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 composite structure comprising a tubular frame and comprising a tubular polymeric inner surface and a tubular polymeric outer surface, wherein at least one of the tubular polymeric inner surface and tubular polymeric outer surface comprises a plurality of electrospun poly(tetrafluoroethylene) (PTFE) nanofibers, and wherein the PTFE nanofibers have a density such that there is a range of distances of about 0.1μ

to about 50μ

between points of contact of the nanofibers.

2. The composite structure of claim 1, wherein both the tubular polymeric inner surface and tubular polymeric outer surface comprise a plurality of electrospun PTFE nanofibers.

3. The composite structure of claim 1, further comprising one or more additional layers of polymeric material.

4. The composite structure of claim 3, wherein the one or more additional layers of polymeric material comprises a second plurality of electrospun poly(tetrafluoroethylene) (PTFE) nanofibers.

5. The composite structure of claim 3, wherein the one or more additional layers of polymeric material comprises nylon, polyurethane, polyester, fluorinated ethylene propylene, or a combination thereof in the form of electrospun fibers.

6. The composite structure of claim 3, wherein at least one of the tubular polymeric inner surface, the tubular polymeric outer surface, and the one or more additional layers of polymeric materials comprises expanded PTFE.

7. The composite structure of claim 3, wherein the one or more additional layers of polymeric material comprises a thermoplastic or elastic material.

8. The composite structure of claim 1, wherein one of the tubular polymeric inner surface and tubular polymeric outer surface comprises nylon, polyurethane, polyester, fluorinated ethylene propylene, or a combination thereof in the form of electrospun fibers.

9. The composite structure of claim 1, wherein the tubular polymeric inner surface and a tubular polymeric outer surface have different pore sizes.

10. The composite structure of claim 1, wherein the tubular frame comprises a metal.

11. The composite structure of claim 1, wherein the tubular frame comprises stainless steel, platinum, gold, titanium, polymer, or nitinol.

12. The composite structure of claim 1, wherein the tubular frame comprises a stent.

13. The composite structure of claim 1, further comprising a bioactive agent.

14. The composite structure of claim 13, wherein the bioactive agent is selected from the group consisting of antibiotics, antifungals, antivirals, anticonvulsants, antidepressants, antiparkinsonism drugs, cardiovascular agents, antineoplastics, corticosteroids, NSAIDs, hormones, growth factors, carbonic anhydrase inhibitors, prostaglandins, antiangiogenic agents, neuroprotectants, neurotrophins, growth factors, cytokines, chemokines, cells, tissues, and combinations thereof.

15. The composite structure of claim 1, wherein each of the inner surface and outer surface comprise at least one electrospun layer of a plurality of electrospun PTFE nanofibers.

16. The composite structure of claim 15, wherein the pore structure of one or more of the electrospun layers as defined by ASTM F316 is between about 0.05 μ

m and about 50 μ

m.

17. The composite structure of claim 15, wherein one or more of the electrospun layers has a porosity to enhance cellular ingrowth or attachment.

18. The composite structure of claim 15, wherein one or more of the electrospun layers has a porosity to inhibit cellular ingrowth or attachment.

19. The composite structure of claim 1, wherein the composite structure is comprised primarily of micron and sub-micron sized electrostatically spun PTFE fibers in random orientation on the frame.

20. The composite structure of claim 1, wherein the tubular polymeric inner surface comprises a plurality of electrospun poly(tetrafluoroethylene) (PTFE) nanofibers.

21. A composite structure comprising a tubular frame and comprising at least three tubular polymeric layers associated therewith, wherein one tubular polymeric layer is positioned to form the inner surface of the composite structure and one tubular polymeric layer is positioned to form the outer surface of the composite structure, wherein at least one of the three tubular polymeric layers comprises a plurality of electrospun poly(tetrafluoroethylene) (PTFE) nanofibers, and wherein the nanofibers have a density such that there is a range of distances of about 0.1μ

to about 50μ

between points of contact of the nanofibers.

22. The composite structure of claim 21, wherein at least two of the tubular polymeric layers comprise a plurality of electrospun PTFE nanofibers.

23. The composite structure of claim 21, wherein at least one of the three tubular polymeric layers is positioned to form the inner surface of the composite structure and the one tubular polymeric layer positioned to form the outer surface of the composite structure comprises a plurality of electrospun PTFE nanofibers.

24. The composite structure of claim 21, wherein at least one of the tubular polymeric layers comprises nylon, polyurethane, polyester, fluorinated ethylene propylene, or a combination thereof in the form of electrospun fibers.

25. The composite structure of claim 21, wherein at least one of the tubular polymeric layer positioned to form the inner surface of the composite structure and the tubular polymeric layer positioned to form the outer surface of the composite structure comprises nylon, polyurethane, polyester, fluorinated ethylene propylene, or a combination thereof in the form of electrospun fibers.

26. The composite structure of claim 21, wherein the tubular polymeric layer positioned to form the inner surface of the composite structure and the tubular polymeric layer positioned to form the outer surface of the composite structure have different pore sizes.

27. The composite structure of claim 21, wherein the tubular frame comprises a metal.

28. The composite structure of claim 21, wherein the tubular frame comprises stainless steel, platinum, gold, titanium, polymer, or nitinol.

29. The composite structure of claim 21, wherein the tubular frame comprises a stent.

30. The structure of claim 21, further comprising a bioactive agent.

31. The structure of claim 30, wherein the bioactive agent is selected from the group consisting of antibiotics, antifungals, antivirals, anticonvulsants, antidepressants, antiparkinsonism drugs, cardiovascular agents, antineoplastics, corticosteroids, NSAIDs, hormones, growth factors, carbonic anhydrase inhibitors, prostaglandins, antiangiogenic agents, neuroprotectants, neurotrophins, growth factors, cytokines, chemokines, cells, tissues, and combinations thereof.

32. The composite structure of claim 21, wherein each of the inner surface and outer surface comprise at least one electrospun layer of a plurality of electrospun PTFE nanofibers.

33. The composite structure of claim 32, wherein the pore structure of one or more of the electrospun layers as defined by ASTM F316 is between about 0.05 μ

m and about 50 μ

m.

34. The composite structure of claim 32, wherein one or more of the electrospun layers has a porosity to enhance cellular ingrowth or attachment.

35. The composite structure of claim 32, wherein one or more of the electrospun layers has a porosity to inhibit cellular ingrowth or attachment.

36. The composite structure of claim 21, wherein the composite structure is comprised primarily of micron and sub-micron sized electrostatically spun PTFE in random orientation on the frame.

37. The composite structure of claim 21, wherein the tubular polymeric layer positioned to form the inner surface comprises a plurality of electrospun poly(tetrafluoroethylene) (PTFE) nanofibers.