Granted Patent B2

US 12,233,185 · App. 17/239,013 · Granted Feb 25, 2025

Inventors: Michael P. Francis (Norfolk, VA); Stella Petrova (Blacksburg, VA); Nicholas Thayer (Morrisville, NC)

Assignee: Embody, Inc.

A61L27/24A61L17/105A61L17/14A61L27/3804A61L27/386D01D5/02D01D5/06D01D5/38D01D7/00D01F4/00A61L2430/10

Abstract

Claims (41)

1. An extruded collagen fiber, wherein the extruded collagen fiber has the following characteristics:

an ultimate tensile strength of between about 20 MPa to about 1,700 MPa;

a modulus of elasticity of between about 200 MPa to about 20,000 MPa;

a strain at break of between about 2 percent and about 45 percent elongation;

an average fiber diameter between about 10 μm and less than about 200 μm;

maintains its strength after soaking in Dulbecco's Phosphate Buffered Solution (“DPBS”) at room temperature for about 1 hour; and

promotes an elevated pro-regenerative M2 macrophage response in vivo, wherein the fiber further comprises sub-fibers that are cross-linked with glyoxal.

2. The extruded collagen fiber of claim 1 , wherein the fiber has a cross section selected from the group consisting of substantially circular, ovoid, square, rectangular, ribbon-like, triangular, or irregular shapes.

3. The extruded collagen fiber of claim 1 , wherein the collagen is selected from the group consisting of clinical grade collagen, atelocollagen, telocollagen, recombinant collagen, and blends thereof.

4. The extruded collagen fiber of claim 1 , wherein the collagen is type I collagen.

5. The extruded collagen fiber of claim 1 , wherein the extruded fiber further comprises one or more bio-acceptable polymers.

6. The extruded collagen fiber of claim 1 , further comprising adhered tenocytes;

wherein the tenocytes retain at least about 75% cell viability and at least about 95% cell survival after about seven days incubation under conventional mammalian cell culture conditions of temperature, pH, and humidity.

7. A plurality of the extruded collagen fibers of claim 1 , wherein the fibers are associated in a form factor that is bundled, braided, interwoven, or twisted.

8. The plurality of the extruded collagen fibers of claim 7 , wherein the form factor is a suture, a construct, a scaffold, a platform, or an internal brace.

9. The plurality of the extruded collagen fibers of claim 8 , wherein the form factor is a suture;

wherein the suture is resorbable; and

wherein the suture exhibits cellular infiltration after implantation in a subject.

10. An extruded biopolymer fiber comprising collagen, wherein the biopolymer fiber has the following characteristics:

an ultimate tensile strength of between about 20 MPa to about 170 MPa;

a modulus of elasticity of between about 200 MPa to about 3,500 MPa;

a strain at break of between about 4 percent and about 12 percent elongation;

an average fiber diameter between about 16 μm and less than about 200 μm after drying;

maintains its strength after soaking in biological fluid for about 1 hour; and

promotes an elevated pro-regenerative M2 macrophage response in vivo, wherein the fiber further comprise sub-fibers that are cross-linked with glyoxal.

11. The extruded biopolymer fiber of claim 10 , wherein the biopolymer fiber allows infiltration of cellular growth.

12. The extruded biopolymer fiber of claim 10 , wherein the biopolymer fiber further comprises one or more bio-acceptable polymers.

13. The extruded biopolymer fiber of claim 10 , further comprising adhered tenocytes;

wherein the tenocytes retain at least about 75% cell viability and at least about 95% cell survival after about seven days incubation under conventional mammalian cell culture conditions of temperature, pH, and humidity.

14. A plurality of the extruded biopolymer fibers of claim 10 , wherein the fibers are associated in a form factor that is bundled, braided, interwoven, or twisted.

15. The plurality of the extruded biopolymer fibers of claim 14 , wherein the form factor is a bundle.

16. An extruded biopolymer fiber, wherein the biopolymer fiber comprises collagen; and

wherein the biopolymer fiber has the following characteristics:

an ultimate tensile strength of between about 20 MPa to about 170 MPa;

a modulus of elasticity of between about 200 MPa to about 3,500 MPa;

a strain at break of between about 4 percent and about 12 percent elongation;

an average fiber diameter between about 16 μm and about 70 μm after soaking for about 1 hour in phosphate-buffered saline solution; and

maintains its strength after soaking in biological fluid for about 24 hours, wherein the fiber further comprise sub-fibers that are cross-linked with glyoxal.

17. The extruded biopolymer fiber of claim 16 , further comprising adhered tenocytes;

wherein the tenocytes retain at least about 75% cell viability and at least about 95% cell survival after about seven days incubation under conventional mammalian cell culture conditions of temperature, pH, and humidity.

18. A plurality of the extruded biopolymer fibers of claim 16 , wherein the fibers are associated in a form factor that is bundled, braided, interwoven, or twisted.

Assignments (2)

Continuity (3)

References Cited (299)