COMPOSITE PROSTHETIC DEVICES

• US 20160067374A1
• Filed: 09/18/2015
• Published: 03/10/2016
• Est. Priority Date: 01/16/2009
• Status: Abandoned Application

• Current Assignee: Zeus Industrial Products, Inc.
• Original Assignee: Zeus Industrial Products, Inc.
• Inventors: Puckett, Sabrina D., Manasco, Joshua L., Ballard, Robert L., Anneaux, Bruce L.
• Application Number:
  US14/858,556
• Publication Number:
  US 20160067374A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• 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: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: D01D 10/02 Heat treatment heating for finishing D02J13/00
• CPC Class Codes: D01D 5/0038 the fibre formed by solvent evaporation, i.e. dry electro-spinning
• CPC Class Codes: D01F 6/48 of polymers of halogenated hydrocarbons
• CPC Class Codes: D04H 1/4318 Fluorine series
• CPC Class Codes: D04H 1/4374 using different kinds of webs, e.g. by layering webs
• CPC Class Codes: D04H 1/544 Olefin series
• CPC Class Codes: D04H 1/558 in combination with mechanical or physical treatments other than embossing
• CPC Class Codes: D04H 1/559 the fibres being within layered webs
• CPC Class Codes: D04H 1/728 by electro-spinning electro-spinning methods and apparatus D01D5/0007

Abstract

The present disclosure provides composite prosthetic devices comprising 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 comprise various materials and the properties of the prosthetic devices can be tailored for use in a range of different applications.

Claims

1. A polymeric material comprising:

a membrane comprised of serially deposited polymeric fibers, the polymeric fibers having been stretched in a first direction after the fibers are serially deposited.

2. The polymeric material of claim 1, wherein the serially deposited fibers comprise sintered fibers.

3. The polymeric material of claim 1, wherein the serially deposited fibers are exposed to an elevated temperature.

4. The polymeric material of claim 1, wherein the serially deposited fibers are generally aligned in the first direction.

5. The polymeric material of claim 1, wherein the membrane is more resistant to creep in the first direction after the membrane is stretched.

6. The polymeric material of claim 1, wherein the serially deposited polymeric fibers have been stretched in a second direction.

7. A serially deposited fiber mat comprising a portion of a medical appliance, the serially deposited fiber mat comprising:

serially deposited fibers wherein 95% of the fibers have diameters from 50 nm to 6 μ

m.

8. The serially deposited fiber mat of claim 7, wherein the fibers have an average fiber density from 5,000 to 150,000 fibers per mm².

9. The serially deposited fiber mat of claim 7, wherein the fibers define between 100 and 100,000 intersections per mm².

10. A serially deposited fiber mat comprising a portion of a device, the serially deposited fiber mat comprising serially deposited fibers, wherein all of the fibers have diameters of 400 nm to 3200 nm.

11. The serially deposited fiber mat of claim 10, wherein the serially deposited fiber mat comprises spun polytetrafluoroethylene fibers.

12. The serially deposited fiber mat of claim 10, wherein all of the fibers have diameters from 800 nm to 2.4 μ

m.

13. The serially deposited fiber mat of claim 10, wherein the serially deposited fibers have an average fiber density from 135 to 326,400 fibers per mm².

14. The serially deposited fiber mat of claim 10, wherein the largest pore diameter is from 2.54 μ

m to 9.96 μ

m.

15. The serially deposited fiber mat of claim 10, wherein the fibers define between 2 and 2.9×

10¹² intersections per mm².

16. A serially deposited fiber mat comprising a portion of a medical device, the serially deposited fiber mat comprising serially deposited fibers, wherein all of the fibers have diameters of 10 nm to 2000 nm.

17. The serially deposited fiber mat of claim 16, wherein the serially deposited fiber mat comprises spun polytetrafluoroethylene fibers.

18. The serially deposited fiber mat of claim 16, wherein the fibers have an average fiber density from 344 to 46.1 million fibers per mm².

19. The serially deposited fiber mat of claim 16, wherein the pore diameters are from about 0.05 to about 50 μ

m.

20. A method of manufacturing a polymeric material comprising:

obtaining a membrane comprising a mat of polymeric fibers;

sintering the membrane; and

expanding the membrane in a first direction to at least partially elongate the membrane in the first direction.

21. The method of claim 20, wherein the expanding comprises expanding during sintering.

22. The method of claim 20, wherein obtaining the membrane comprises:

serially depositing polymeric fibers on a collection surface to form a membrane.

23. The method of claim 20, wherein the membrane is sintered at a temperature of 288°

C. to 482°

C.

24. The method of claim 20, wherein sintering the membrane comprises heating the membrane to at least the crystalline melt temperature of the polymeric fibers.

25. The method of claim 20, wherein expanding the membrane comprises expanding the membrane such that the polymeric fibers tend to align in the first direction.

26. The method of claim 20, wherein expanding the membrane comprises expanding the membrane on the order of 103 to 200% of its original length in the first direction.

27. The method of claim 20, further comprising expanding the membrane in a second direction.

28. The method of claim 20, further comprising constraining the membrane, wherein the sintering is conducted while the membrane is constrained in place on a surface on which it was collected.

29. The method of claim 20, wherein obtaining the membrane comprises:

mixing a PTFE-water dispersion comprising from 50% to 80% PTFE solids by weight with PEO to create a mixture having 0.032 to 0.052 gm PEO/mL of total mixture;

spinning the mixture;

collecting spun fibers on a cylindrical surface; and

wherein the sintering is at a temperature of 288°

C. to 482°

C.

30. The method of claim 20, wherein obtaining a membrane comprising a mat of sintered polymeric fibers comprises:

mixing a PTFE-water dispersion comprising from 10% to 85% PTFE solids by weight with PEO to create a mixture having about 1 to 10 wt % PEO/mL of total mixture or more;

spinning the mixture at 30-60 RPM;

collecting spun fibers on a rotating tube assembly; and

sintering the collected fibers at a temperature of 35°

C. to 485°

C.

31. The method of claim 20, wherein expanding the membrane comprises stretching the membrane to at least 150% of its original length in the first direction.