Tissue substitute materials and methods for tissue repair

• US 10,632,228 B2
• Filed: 05/12/2016
• Issued: 04/28/2020
• Est. Priority Date: 05/12/2016
• Status: Active Grant

• Current Assignee: Acera Surgical, Inc.
• Original Assignee: Acera Surgical, Inc.
• Inventors: MacEwan, Matthew
• Primary Examiner(s): Salvatore, Lynda
• Application Number:
  US15/152,726
• Publication Number:
  US 20170326270A1
• Time in Patent Office: 1,447 Days
• Field of Search: 623 2372, 427 231, 264466
• CPC Class Codes: A61L 2430/32 for nerve reconstruction
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Non-woven graft materials for use in specialized surgical procedures such as neurosurgical procedures, methods for making the non-woven graft materials, and methods for repairing tissue such as neurological tissue using the non-woven graft materials are disclosed. More particularly, disclosed are non-woven graft materials including at least two distinct fiber compositions composed of different polymeric materials, methods for making the non-woven graft materials and methods for repairing tissue in an individual in need thereof using the non-woven graft materials.

Claims

1. A resorbable non-woven graft material consisting of a single layer comprising:

a first electrospun non-woven fiber composition, wherein the first electrospun non-woven fiber composition consists of poly (glycolic acid) and

a second electrospun non-woven fiber composition, wherein the second electrospun non-woven fiber composition comprises poly(lactide-co-caprolactone),

wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprise different polymers, and

wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are commingled throughout a thickness of the resorbable non-woven graft material.

2. The non-woven graft material of claim 1, wherein the first electrospun non-woven fiber composition to the second electrospun non-woven fiber composition ratio ranges from about 10:

1 to about 1;

10.

3. The non-woven graft material of claim 1, comprising a mean pore size of from about 10 μ

m² to about 10,000 μ

m².

4. The non-woven graft material of claim 1, wherein at least one of the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprise a mean fiber diameter of less than 5 μ

m.

5. The non-woven graft material of claim 1, wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are uniformly distributed throughout the material.

6. The non-woven graft material of claim 1, wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are independently distributed in a pattern throughout the material.

7. The non-woven graft material of claim 1, further comprising at least one projection arising from a surface of the non-woven graft material, at least one indentation in a surface of a non-woven graft material, and combinations thereof.

8. The non-woven graft material of claim 1, further comprising:

a plurality of projections arising from a surface of the non-woven graft material, wherein the plurality of projections are randomly distributed on the surface of the non-woven graft material; and

a plurality of indentations in the surface of the non-woven graft material, wherein the plurality of indentations are randomly distributed on the surface of the non-woven graft material.

9. The non-woven graft material of claim 8, wherein at least one of the plurality of indentations comprises a gradual gradient.

10. The non-woven graft material of claim 8, wherein the plurality of indentations comprise a substantially uniform depth.

11. The non-woven graft material of claim 8, wherein at least one of the plurality of projections comprises a gradual gradient.

12. The non-woven graft material of claim 8, wherein the plurality of projections comprise a substantially uniform depth.

13. A resorbable non-woven graft material consisting of a single layer comprising:

a first electrospun non-woven fiber composition, wherein the first electrospun non-woven fiber composition consists of poly(glycolic acid); and

a second electrospun non-woven fiber composition, wherein the second electrospun non-woven fiber composition consists of poly(lactide-co-caprolactone),

wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are commingled throughout a thickness of the resorbable non-woven graft material.

14. The non-woven graft material of claim 13, further comprising:

a plurality of projections arising from a surface of the non-woven graft material, wherein the plurality of projections are randomly distributed on the surface of the non-woven graft material; and

a plurality of indentations in the surface of the non-woven graft material, wherein the plurality of indentations are randomly distributed on the surface of the non-woven graft material.

15. The non-woven graft material of claim 14, wherein at least one of the plurality of indentations comprises a gradual gradient.

16. The non-woven graft material of claim 14, wherein the plurality of indentations comprise a substantially uniform depth.

17. The non-woven graft material of claim 14, wherein at least one of the plurality of projections comprises a gradual gradient.

18. The non-woven graft material of claim 14, wherein the plurality of projections comprise a substantially uniform depth.

19. A resorbable non-woven graft material consisting of a single layer comprising:

a first electrospun non-woven fiber composition, wherein the first electrospun non-woven fiber composition comprises poly(glycolic acid);

a second electrospun non-woven fiber composition, wherein the second electrospun non-woven fiber composition comprises poly(lactide-co-caprolactone),

wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition comprise different polymers, and

wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are commingled throughout a thickness of the resorbable non-woven graft material using an electrospinning process;

a plurality of projections arising from a surface of the non-woven graft material, wherein the plurality of projections are randomly distributed in an uncontrolled configuration on the surface of the non-woven graft material; and

a plurality of indentations in the surface of the non-woven graft material, wherein the plurality of indentations are randomly distributed in an uncontrolled configuration on the surface of the non-woven graft material.

20. The non-woven graft material of claim 19, wherein the first electrospun non-woven fiber composition and the second electrospun non-woven fiber composition are independently distributed in a pattern throughout the material.