TISSUE REPAIR DEVICES AND SCAFFOLDS

• US 20150150681A1
• Filed: 05/30/2013
• Published: 06/04/2015
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: New York University
• Original Assignee: New York University
• Inventors: Ricci, John L., Thompson, Van P., Clark, Elizabeth, Coelho, Paulo, Rekow, Elizabeth Dianne, Smay, James
• Granted Patent: US 10,945,845 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30574 with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30962 using stereolithography
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/30985 using three dimensional printing [3DP]
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/025 Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

The present invention relates to multiphasic, three-dimensionally printed, tissue repair devices or scaffolds useful for promoting bone growth and treating bone fracture, defect or deficiency, methods for making the same and methods for promoting bone growth and treating bone fracture, defect or deficiency using the same. The scaffold has a porous bone ingrowth area containing interconnected struts surrounded by a microporous shell. At the ends of the scaffold, the shell may be extended as a guide flange to stabilize the scaffold between ends of bone. The center of the scaffold may be empty and may serve as a potential marrow space. The porous ingrowth structure may be infiltrated with a soluble filler or carrier, such as, for example calcium sulfate which may be infiltrated with one or more of an antibiotic, a growth factor, a differentiation factors, a cytokine, a drug, or a combination of these agents.

Claims

1. A tissue repair device or scaffold having a porous bone ingrowth structure containing interconnected struts surrounded by a microporous shell.

2. A tissue repair device or scaffold according to claim 1 wherein the microporous shell is extended as a guide to stabilize the tissue repair device or scaffold between one or more ends of bone.

3. The tissue repair device or scaffold according to claim 1 having a center defined by an empty space.

4. The tissue repair device or scaffold according to claim 1 wherein the porous ingrowth structure is infiltrated with a soluble filler or carrier.

5. The tissue repair device or scaffold according to claim 4 wherein the soluble filler or carrier is calcium sulfate.

6. The tissue repair device or scaffold according to claim 4 wherein the soluble filler or carrier is infiltrated with one or more of an antibiotic, a growth factor, a differentiation factor, a cytokine, a drug, or a combination thereof.

7. The tissue repair device or scaffold according to claim 1 wherein the struts are from about 100-350 μ

m diameter.

8. The tissue repair device or scaffold according to claim 1 wherein the struts are within about 2×

or substantially the same diameter as bone trabeculae.

9. The tissue repair device or scaffold according to claim 1 wherein one or more struts are separated longitudinally by a space of at least 500 μ

m.

10. The tissue repair device or scaffold according to claim 1 being porous and comprising mesopores present in a size generally more than about 20 μ

m diameter.

11. The tissue repair device or scaffold according to claim 1 wherein the struts are arranged in a substantially linear arrangement.

12. The tissue repair device or scaffold according to claim 1 being resorbable so that after about 8 weeks presence in vivo, at least about 25% of the tissue repair device or scaffold is resorbed.

13. The tissue repair device or scaffold according to claim 1 being at least about 50% porous.

14. The tissue repair device or scaffold according to claim 1 being operable to encourage and provide bone growth such that after about 8 weeks presence in vivo, at least about 25% of the tissue repair device or scaffold is replaced by bone.

15. The tissue repair device or scaffold according to claim 1 comprising micropores or nanopores having a diameter of about 0.1-1 μ

m.

16. The tissue repair device or scaffold according to claim 15 wherein one or more micropores or nanopores are infiltrated with solubilized collagen.

17. The tissue repair device or scaffold according to claim 1 produced by a three dimensional printing method.

18. A method for promoting bone growth or treating bone fracture, defect or deficiency comprising providing a tissue repair device or scaffold having a porous bone ingrowth structure containing interconnected struts surrounded by a microporous shell according to claim 1 in vivo to a region featuring a bone deficiency, fracture or void.

19. A method for producing a tissue repair device or scaffold useful for promoting bone growth or treating bone fracture, defect or deficiency having a porous bone ingrowth region containing interconnected struts surrounded by a microporous shell, comprising:

(a) providing microporous shell that may function to attach but limit soft tissue ingrowth, and (b) infiltrating the porous ingrowth structure with a soluble filler or carrier.

20. A method according to claim 19 further comprising (c) infiltrating the porous ingrowth structure with one or more of an antibiotic, a growth factor, a differentiation factors, a cytokine, a drug, or a combination of these agents.