Vascular prosthesis and method for production thereof

• US 7,115,220 B2
• Filed: 12/17/2001
• Issued: 10/03/2006
• Est. Priority Date: 12/19/2000
• Status: Expired due to Fees

• Current Assignee: Nicast Ltd.
• Original Assignee: Nicast Ltd.
• Inventors: Bar, Eli, Dubson, Alexander
• Primary Examiner(s): Theisen, Mary Lynn
• Application Number:
  US10/433,622
• Publication Number:
  US 20040054406A1
• Time in Patent Office: 1,751 Days
• Field of Search: 264437-441, 264/6, 264/10, 264/413, 264/465, 425/174.8 E
• US Class Current: 264/6
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 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 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 67/20 for porous or cellular articles, e.g. of foam plastics, coarse-pored chemical aspects of working up macro-molecular substances to porous or cellular articles C08J9/00
• CPC Class Codes: D01D 5/0007 Electro-spinning non-woven fabrics produced by electro-spinning D04H1/728
• CPC Class Codes: D01D 5/0069 characterised by the spinning section, e.g. capillary tube, protrusion or pin
• CPC Class Codes: D01D 5/0092 characterised by the electrical field, e.g. combined with a magnetic fields, using biased or alternating fields
• CPC Class Codes: D01D 5/18 by means of rotating spinnerets
• CPC Class Codes: D04H 1/728 by electro-spinning electro-spinning methods and apparatus D01D5/0007
• CPC Class Codes: D04H 3/07 otherwise than in a plane, e.g. in a tubular way
• CPC Class Codes: D04H 3/16 with bonds between thermoplastic filaments produced in association with filament formation, e.g. immediately following extrusion
• CPC Class Codes: Y10T 428/13 Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/1372 Randomly noninterengaged or randomly contacting fibers, filaments, particles, or flakes
• CPC Class Codes: Y10T 428/139 : Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 442/614 : Strand or fiber material specified as having microdimensions [i.e., microfiber]

Abstract

A vascular prosthesis comprising a first layer having a predetermined first porosity and a second layer having a predetermined second porosity, wherein the first layer and the second layer are each made of first and second electrospun polymer fibers.

Claims

1. A method of producing a vascular prosthesis, the method comprising:

electrospinning a first liquefied polymer onto a precipitation electrode hence providing a first layer having a predetermined first porosity;

electrospinning a second liquefied polymer onto said precipitation electrode hence providing a second layer having a predetermined second porosity being larger than said predetermined first porosity; and

electrospinning at least one additional liquefied polymer onto said precipitation electrode prior to the step of electrospinning the second liquefied polymer, hence providing at least one intermediate layer interposed between said first layer and said second layer.

2. The method of claim 1, wherein said precipitation electrode is a rotating mandrel.

3. The method of claim 1, wherein each of said electrospinning steps comprising:

(a) charging said liquefied polymer thereby producing a charged liquefied polymer;

(b) subjecting said charged liquefied polymer to a first electric field; and

(c) dispensing said charged liquefied polymers within said first electric field in a direction of said precipitation electrode.

4. The method of claim 3, further comprising providing a second electric field defined by a subsidiary electrode being at a second potential relative to said precipitation electrode, said second electric field being for modifying said first electric field.

8. The method of claim 3, wherein said first electric field is defined between said precipitation electrode and a dispensing electrode being at a first potential relative to said precipitation electrode.

9. The method of claim 4, wherein said subsidiary electrode serves for reducing non-uniformities in said first electric field.

10. The method of claim 4, wherein said subsidiary electrode serves for controlling fiber orientation of said polymer fiber shell generated upon said precipitation electrode.

11. The method of claim 1, wherein said first layer is an inner layer and said second layer is an outer layer.

12. The method of claim 1, wherein each of said first layer and said second layer is independently of a tubular structure.

31. The method of claim 1, wherein said at least one intermediate layer has a predetermined porosity.

32. The method of claim 1, wherein each of said first liquefied polymer and said second liquefied polymer are independently biocompatible.

33. The method of claim 1, wherein each of said first liquefied polymer, said second liquefied polymer and said at least one additional liquefied polymer are independently biocompatible.

34. The method of claim 1, wherein each of said first liquefied polymer, said second liquefied polymer and said at least one additional liquefied polymer is independently selected from the group consisting of polyethylene terephtalat fibers and polyurethane fibers.

5. A method of producing a vascular prosthesis, the method comprising:

electrospinning a first liquefied polymer onto a precipitation electrode hence providing a first layer having a predetermined first porosity;

electrospinning a second liquefied polymer onto said precipitation electrode hence providing a second layer having a predetermined second porosity;

electrospinning at least one additional liquefied polymer onto said precipitation electrode prior to the step of electrospinning the second liquefied polymer, hence providing at least one intermediate layer interposed between said first layer and said second layer; and

winding a filament around at least one of said first layer, said second layer, and at least one of said at least one intermediate layer hence providing at least one layer which comprises at least one coiled pattern.

6. The method of claim 5, wherein said step of winding and at least one of said steps of electrospinning are performed simultaneously.

7. The method of claim 5, further comprising coating said filament by a polyurethane solution prior to said step of winding said filament.

13. The method of claim 5, wherein said filament is formed by polymer fiber extruder.

14. The method of claim 13, wherein said polymer filament extruder includes a bath for holding a melted polymer.

15. The method of claim 14, wherein said melted polymer is a biocompatible melted polymer.

16. The method of claim 15, wherein at least a portion of said biocompatible melted polymer includes a melted polyurethane.

17. The method of claim 13, further comprising cooling said filament by airflow upon exiting said polymer fiber extruder.

18. The method of claim 7, wherein said coating comprises dipping said filament into said polyurethane solution.

19. The method of claim 5, further comprising heating said filament prior to, during or subsequent to said step of winding said filament.

26. The method of claim 5, wherein said filament is selected from the group consisting of a polypropylene filament and a polyurethane filament.

27. The method of claim 5, wherein said filament has a cross-section selected from the group consisting of a circular cross section, an ellipsoid cross section a polygonal cross section and an irregular pattern cross section.

28. The method of claim 5, wherein said at least one intermediate layer includes a plurality of adhesion sublayers, alternately interposed between said first layer and said coiled pattern, between said coiled pattern and said second layer, and between two congruent coiled patterns.

29. The method claim 28, wherein said adhesion sublayers are impervious adhesion sublayers.

30. The method of claim 28, wherein said adhesion sublayers are formed from electrospun polymer fibers.

20. A method of producing a vascular prosthesis, the method comprising:

electrospinning a first liquefied polymer onto a rotating mandrel hence providing a first layer having a predetermined first porosity;

electrospinning a second liquefied polymer onto said rotating mandrel hence providing a second layer having a predetermined second porosity; and

electrospinning at least one additional liquefied polymer onto said rotating mandrel prior to the step of electrospinning the second liquefied polymer, hence providing at least one intermediate layer interposed between said first layer and said second layer;

wherein the method further comprising heating said mandrel prior to, during or subsequent to said step of electrospinning.

21. The method of claim 20, wherein said heating of said mandrel is selected from the group consisting of external heating and internal heating.

22. The method of claim 21, wherein said external heating is by at least one infrared radiator.

23. The method of claim 21, wherein said at least one infrared radiator is an infrared lamp.

24. The method of claim 21, wherein said internal heating is by a built-in heater.

25. The method of claim 24, wherein said built-in heater is an Ohmic built-in heater.

35. A method of producing a vascular prosthesis, the method comprising:

electrospinning a first liquefied polymer onto a precipitation electrode hence providing a first layer having a predetermined first porosity;

electrospinning a second liquefied polymer onto said precipitation electrode hence providing a second layer having a predetermined second porosity;

electrospinning at least one additional liquefied polymer onto said precipitation electrode prior to the step of electrospinning the second liquefied polymer, hence providing at least one intermediate layer interposed between said first layer and said second layer; and

incorporating at least one drug within at least one of said first liquefied polymer, said second liquefied polymer and said at least one additional liquefied polymer, for delivery of said at least one drug into a body vasculature during or after implantation of the vascular prosthesis within said body vasculature;

wherein each of said first liquefied polymer, said second liquefied polymer and said at least one additional liquefied polymer are independently combination of a biodegradable liquefied polymer and a biostable liquefied polymer.