Composite prosthetic devices

• US 10,010,395 B2
• Filed: 10/22/2014
• Issued: 07/03/2018
• Est. Priority Date: 04/05/2012
• Status: Active Grant

• Current Assignee: Zeus Co. LLC
• Original Assignee: Zeus Industrial Products, Inc.
• Inventors: Puckett, Sabrina D., Manasco, Joshua, Ballard, Robert L., Anneaux, Bruce L.
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US14/520,368
• Publication Number:
  US 20160081783A1
• Time in Patent Office: 1,350 Days
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: D01D 10/02 Heat treatment heating for finishing D02J13/00
• CPC Class Codes: D01D 5/003 the material being a polymer solution or dispersion D01D5/0053 takes precedence
• CPC Class Codes: D01F 6/12 from polymers of fluorinated hydrocarbons
• 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

Abstract

The present disclosure provides composite prosthetic devices including two or more layers of electrospun polymers and methods of preparation thereof. In some embodiments, the two or more layers can be porous and in other embodiments, one or more components is nonporous. The composite prosthetic devices can include various materials and the properties of the prosthetic devices can be tailored for use in a range of different applications.

Claims

1. A method for producing a composite prosthetic device comprising:

combining, to give a composite prosthetic device precursor, (i) a structural frame, (ii) one or more first porous layers comprising electrospun poly(tetrafluoroethylene), (iii) one or more second porous layers comprising a first electrospun polymer, (iv) one or more third porous layers comprising electrospun poly(tetrafluoroethylene), and (v) one or more fourth porous layers comprising a second electrospun polymer, wherein at least one of the one or more second porous layers is disposed on at least part of a first side of the structural frame, and at least one of the one or more first porous layers is disposed on the at least one of the one or more second porous layers, and wherein at least one of the one or more fourth porous layers is disposed on at least part of a second side of the structural frame, and at least one of the one or more third porous layers is disposed on the at least one of the one or more fourth porous layers; and

applying pressure, heat, or both pressure and heat to the composite prosthetic device precursor to provide the composite prosthetic device.

2. The method of claim 1, wherein the applying step comprises applying pressure, heat, or both pressure and heat for a time sufficient to result in penetration of the first elecrospun polymer of at least one of the one or more second porous layers into one or more pores of at least one of the one or more first porous layers.

3. The method of claim 1, wherein the first electrospun polymer is the same as the second electrospun polymer.

4. The method of claim 1, wherein the first side of the structural frame forms an inside diameter of the structural frame, and the second side of the structural frame forms an outside diameter of the structural frame.

5. The method of claim 1, wherein at least one of the one or more first porous layers and the one or more third porous layers comprise sintered electrospun poly(tetrafluoroethylene).

6. The method of claim 1, wherein the combining step comprises placing the structural frame around the one or more second porous layers.

7. The method of claim 6, wherein the structural frame is a stent.

8. The method of claim 1, wherein the structural frame comprises open spaces through which at least one of the first electrospun polymer and the second electrospun polymer penetrates.

9. The method of claim 1, wherein the combining comprises wrapping at least one of the one or more second porous layers around at least one of the one or more first porous layers.

10. The method of claim 1, wherein the combining comprises electrospinning at least one of the one or more second porous layers onto at least one of the one or more first porous layers.

11. The method of claim 1, wherein the first electrospun polymer comprises a solution-electrospun polymer.

12. The method of claim 1, wherein the first electrospun polymer comprises a thermoplastic polymer or a thermoset polymer.

13. The method of claim 1, wherein the first electrospun polymer layer comprises a polyurethane or a silicone.

14. The method of claim 1, wherein the first electrospun polymer is selected from the group consisting of polyether block amide, a polyamide, ultra-high molecular weight polyethylene, a polyester, fluorinated ethylene propylene, polyvinylidene fluoride, perfluoroalkoxy, tetrafluoroethylene/hexafluoropropylene/vinylidene fluoride copolymer, poly(ethylene-co-tetrafluoroethylene), ethylene chlorotrifluoroethylene, polychlorotrifluoroethylene, and copolymers, blends, and derivatives thereof.

15. The method of claim 1, wherein the first electrospun polymer comprises unsintered poly(tetrafluoroethylene) and wherein the applying step causes sintering of the composite prosthetic device.

16. The method of claim 1, wherein the applying step comprises applying pressure, heat, or both pressure and heat for a time sufficient to result in the penetration of the first electrospun polymer into pores of the one or more first porous layers.

17. The method of claim 1, wherein both pressure and heat are applied, sequentially or simultaneously.

18. The method of claim 1, wherein the pressure is between about 500 and about 1500 PSI and the temperature is between about 100.degree. C. and about 400.degree. C.

19. The method of claim 1, wherein the applying step is conducted in a pressure vessel.