Multilayer preform obtained by electro-spinning, method for producing a preform as well as use thereof

• US 20110250689A1
• Filed: 10/09/2009
• Published: 10/13/2011
• Est. Priority Date: 10/09/2008
• Status: Active Grant

• Current Assignee: Technische Universiteit Eindhoven
• Original Assignee: Technische Universiteit Eindhoven
• Inventors: Baaijens, Franciscus Petrus Thomas, Cox, Martijn Antonius Johannes, Rubbens, Mirjam Petronella
• Granted Patent: US 9,109,310 B2
• Time in Patent Office: Days
• US Class Current: 435/398
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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: D04H 1/42 characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
• CPC Class Codes: D04H 1/4374 using different kinds of webs, e.g. by layering webs
• CPC Class Codes: D04H 1/43838 Ultrafine fibres, e.g. microfibres
• CPC Class Codes: D04H 1/728 by electro-spinning electro-spinning methods and apparatus D01D5/0007
• CPC Class Codes: D04H 13/00 Other non-woven fabrics
• CPC Class Codes: Y10T 428/2913 Rod, strand, filament or fiber

Abstract

The invention relates a multilayer preform obtained by electro-spinning, which preform is suitable as a scaffold for a prosthesis, which preform comprises at least one layer of microfibres and at least one layer of nanofibres, wherein the pore size of the at least one layer of microfibres is in the range of 1-300 micrometre and in that the pore size of the at least one layer of nanofibres is in the range of 1-300 micrometre. The present invention also relates to a method of producing said preform. The present invention also relates to the use of the present preform as a substrate for growing human or animal tissue thereon. The present invention furthermore relates to a method for growing human or animal tissue on a substrate, wherein the present preform is used as the substrate.

Claims

1. A multilayer preform obtained by electro-spinning, which preform is suitable as a scaffold for a prosthesis, which preform comprises at least one layer of microfibers and at least one layer of nanofibers, characterized in that the pore size of the at least one layer of microfibers is in the range of 1-300 micrometers and in that the pore size of the at least one layer of nanofibers is in the range of 1-300 micrometers.

2. The preform according to claim 1, characterized in that the pore size of the at least one layer of microfibers and/or the at least one layer nanofibers is between 5 and 100 micrometers.

3. The preform according to claim 1, wherein the pore size of all the layers of the preform is between 1 and 300 micrometers, preferably between 5 and 100 micrometers.

4. The preform according to claim 1, wherein the diameter of the microfibers is in the range of 3 to 20 micrometers, preferably 5 to 18 micrometers and in particular 8 to 14 micrometers.

5. The preform according to claim 1, wherein the diameter of the nanofibers is in the range of 50 to 800 nanometers, preferably at least 200 nanometers and in particular at least 400 nanometers, preferably no more than 700 nanometers and in particular no more than 600 nanometers.

6. The preform according to claim 1, wherein the porosity of the layer of microfibers and/or the layer of nanofibers is in the range of 70 to 95%.

7. The preform according to claim 1, wherein the preform has an infinite number of layers having a gradient of diameters.

12. A method of growing human or animal tissue wherein the preform of claim 1 is used as a substrate for growing said human or animal tissue.

13. The method according to claim 12, characterized in that the preform is a substrate for growing a heart valve, one or more blood vessels or a connections thereof or a heartpatch.

8. A method for producing a preform by means of electro-spinning suitable as a scaffold for a prosthesis, characterized in that the method comprises the steps of providing a mould and subsequently applying, in random order, by means of electro-spinning at least one layer of microfibers and at least one layer of nanofibers, in which the pore size of the at least one layer of microfibers is in the range of 1-300 and the pore size of the at least one layer of nanofibers is in the range of 1-300.

9. The method according to claim 8 wherein the step of electro-spinning of the at least one layer of nanofibers is carried out at a temperature below 220 K.

10. The method according to claim 8, wherein the method comprises steps of providing subsequently a mold, electro-spinning at least one layer of nanofibers and subsequently electro-spinning at least one layer of microfibers.

11. The method according to claim 8, wherein no mammalian cells are incorporated into the preform during electro-spinning.

14. A method for producing a preform by means of electro-spinning a preform suitable as a scaffold for a prosthesis.

15. A method for producing a preform by means of an electro-spinning process, comprising the steps of:

a) providing a mould made up of at least two submoulds, which submoulds substantially exclusively comprise convex surfaces;

b) applying at least one layer of nano or microfibers to the surface of at least one of the submoulds of step a) by electro-spinning;

c) combining at least two submoulds selected from the submoulds of step a) and the submoulds of step b);

d) applying at least one layer of nano or microfibers to the surface of the assembly of step c) by electro-spinning to obtain the preform, wherein the preform comprises at least one layer of nanofibers and at least one layer of microfibers. wherein the pore size of the at least one layer of microfibers is in the range of 1-300 micrometers and in that the pore size of the at least one layer of nanofibers is in the range of 1-300 micrometers.