Scaffold for connective tissue repair

• US 20040267362A1
• Filed: 06/30/2003
• Published: 12/30/2004
• Est. Priority Date: 06/30/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Inventors: Schwartz, Herb, Malaviya, Prasanna, Hwang, Julia, Hammer, Joseph
• Granted Patent: US 8,226,715 B2
• Time in Patent Office: Days
• US Class Current: 623/13.15
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2002/0852 Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3662 Ligaments, tendons
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• 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

A connective tissue scaffold including opposed first and second anchoring segments formed from a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to a longitudinal axis of the scaffold and a plurality of bioresorbable polymeric fibers oriented in a direction substantially transverse to a longitudinal axis of the scaffold. A central segment joins the first and second anchoring segments and includes a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to the longitudinal axis of the scaffold. The scaffold can also a tissue particle and/or biological component.

Claims

1. A connective tissue scaffold, comprising:

opposed first and second anchoring segments formed of a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to a longitudinal axis of the scaffold and a plurality of bioresorbable polymeric fibers oriented in a direction substantially transverse to a longitudinal axis of the scaffold; and

a central segment, adjoining the first and second anchoring segments, formed of a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to the longitudinal axis of the scaffold.

2. The scaffold of claim 1, wherein the fibers are formed of a material selected from the group consisting of a synthetic polymer, a natural polymer, and combinations thereof.

3. The scaffold of claim 1, wherein the fibers of the scaffold take longer than six months to resorb when implanted in a biological system.

4. The scaffold of claim 1, wherein the fibers of the first and second anchoring segments are joined in a weave pattern.

5. The scaffold of claim 4, wherein the weave pattern comprises one or more regions having a plurality of longitudinally oriented fibers separated by one or more regions having transversely oriented fibers woven with longitudinally oriented fibers.

6. The scaffold of claim 1, wherein the fibers of the central segment are joined in a braid pattern.

7. The scaffold of claim 1, wherein the first and second anchoring segments comprise a mesh.

8. The scaffold of claim 1, wherein the fiber density of the central segment is less that the fiber density of the first and second anchoring segments.

9. The scaffold of claim 1, wherein the fibers of the central segment are oriented in an annular pattern and a space is centrally formed between the annularly oriented fibers.

10. The scaffold of claim 1, wherein the scaffold further includes a biocompatible, bioresorbable material covering at least a portion of the first and second anchoring segments and the central segment.

11. The scaffold of claim 10, wherein the bioresorbable material is a biological material.

12. The scaffold of claim 11, wherein the bioresorbable material is small intestine submucosa.

13. The scaffold of claim 12, wherein the bioresorbable material is formed over the first and second anchoring segments and the central segment as a wrap, sleeve, or sheath.

14. The scaffold of claim 1, further comprising at least one minced tissue particle that is associated with at least a portion of the scaffold, wherein the at least one minced tissue particle includes an effective amount of viable cells that can migrate out of the minced tissue particle and populate the scaffold.

15. The scaffold of claim 14, wherein the at least one minced tissue particle comprises a bone-free tissue type selected from the group consisting of tendon, ligament, patellar tendon, anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, periosteum, perichondrium, iliotibial band or fascia lata, gracilis tendon, semitendinosis tendon, synovium, skin, and combinations thereof.

16. The scaffold of claim 14, wherein the at least one minced tissue particle comprises a bone tissue type that is placed in the first and second anchoring segments of the scaffold.

17. The scaffold of claim 14, wherein the scaffold further comprises an adhesion agent.

18. The scaffold of claim 17, wherein the adhesion agent comprises an anchoring agent selected from the group consisting of hyaluronic acid, fibrin glue, fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, synthetic acrylate-based adhesives, platelet rich plasma (PRP) gel, platelet poor plasma (PPP) gel, Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans, and combinations thereof.

19. The scaffold of claim 17, wherein the adhesion agent comprises a cross-linking agent selected from the group consisting of divinyl sulfone (DVS), polyethylene glycol, divinyl sulfone (VS-PEG-VS), hydroxyethyl methacrylate divinyl sulfone (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, aldehydes, isocyanates, alkyl and aryl halides, imidoesters, N-substituted maleimides, acylating compounds, carbodiimide, hydroxychloride, N-hydroxysuccinimide, light, pH, temperature, and combinations thereof.

20. The scaffold of claim 14, wherein the at least one minced tissue particle comprises autogeneic tissue.

21. The scaffold of claim 1, wherein the bioresorbable polymeric fibers of the scaffold are made from polymers or copolymers formed from monomers selected from the group consisting of lactide, glycolide, dioxanone, and caprolactone.

22. The scaffold of claim 21, wherein the bioresorbable polymeric fibers of the scaffold are made from a copolymer having a ratio of monomers of about 95:

5 lactide and glycolide.

23. The scaffold of claim 1, wherein the bioresorbable polymeric fibers of the scaffold are made from polymers or polymer blends selected from the group consisting of aliphatic polyesters, a polylactide, a polyglycolide, a polydioxanone, a polycaprolactone, a polyhydroxybutyrate, a polyhydroxybutyrate-co-hydroxyvalerate, a polyorthocarbonate, a polyaminocarbonate, a polytrimethylene carbonate, poly(amino acids), copoly(ether-esters), polyalkylene oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, polyurethanes, poly(ether urethanes), poly(ester urethanes), poly(propylene fumarate), poly(hydroxyalkanoate), and copolymers which incorporate monomers which form such polymers.

24. The scaffold of claim 1, wherein the biosynthetic polymers of the scaffold are made from polymers or copolymers based on repeating units found in collagen, elastin, thrombin, silk, keratin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides, and combinations thereof.

25. The scaffold of claim 1, wherein the scaffold comprises a ligament graft.

26. The scaffold of claim 1, wherein the scaffold comprises a cruciate ligament graft.

27. The scaffold of claim 14, wherein the scaffold further comprises at least one additional biological component applied thereto.

28. The scaffold of claim 27, wherein the at least one additional biological component comprises heterologous or autologous growth factors, proteins, matrix proteins, peptides, antibodies, antibiotics, anti-inflammatories, therapeutic agents, chemotactic agents, cell attachment mediators, biologically active ligands, integrin binding sequence, enzymes, cytokines, glycosaminoglycans, viruses, virus particles, nucleic acids, analgesics, cells, platelets, and combinations thereof.

29. The scaffold of claim 1, further comprising an eyelet formed on opposed ends of the first and second anchoring segment.

30. A connective tissue scaffold, comprising:

opposed first and second anchoring eyelets formed of a plurality of bioresorbable polymeric fibers and defining an open area;

first and second binding regions adjacent the opposed first and second eyelets, the first and second binding regions being formed of a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to a longitudinal axis of the scaffold and in a direction that is not substantially parallel to the longitudinal axis; and

a central segment, adjoining the first and second binding regions, formed of a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to the longitudinal axis of the scaffold.

31. The scaffold of claim 30, wherein the fibers of the first and second binding regions are joined in a weave pattern.

32. The scaffold of claim 30, wherein the scaffold further includes a biocompatible, bioresorbable material covering at least a portion of the first and second binding regions and the central segment.

33. The scaffold of claim 32, wherein the bioresorbable material is a biological material.

34. The scaffold of claim 33, wherein the bioresorbable material is small intestine submucosa.

35. The scaffold of claim 33, wherein the bioresorbable material is formed over the first and second anchoring eyelets, the first and second binding regions, and the central segment as a wrap, sleeve, or sheath.

36. The scaffold of claim 30, further comprising at least one minced tissue particle that is associated with at least a portion of the scaffold, wherein the at least one minced tissue particle includes an effective amount of viable cells that can migrate out of the at least one minced tissue particle and populate the scaffold.

37. The scaffold of claim 36, where in the at least one minced tissue particle comprises a bone-free tissue type selected from the group consisting of tendon, ligament, patellar tendon, anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, periosteum, perichondrium, iliotibial band or fascia lata, gracilis tendon, semitendinosis tendon, synovium, skin and combinations thereof.

38. The scaffold of claim 36, wherein the at least one minced tissue particle comprises a bone tissue type that is placed in the first and second anchoring segments of the scaffold.

39. The scaffold of claim 36, wherein the scaffold further comprises an adhesion agent.

40. The scaffold of claim 39, wherein the adhesion agent comprises an anchoring agent selected from the group consisting of hyaluronic acid, fibrin glue, fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, synthetic acrylate-based adhesives, platelet rich plasma (PRP), Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans, and combinations thereof.

41. The scaffold of claim 39, wherein the adhesion agent comprises a cross-linking agent selected from the group consisting of divinyl sulfone (DVS), polyethylene glycol divinyl sulfone (VS-PEG-VS), hydroxyethyl methacrylate divinyl sulfone (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, aldehydes, isocyanates, alkyl and aryl halides, imidoesters, N-substituted maleimides, acylating compounds, carbodiimide, hydroxychloride, N-hydroxysuccinimide, light, pH, temperature, and combinations thereof.

42. The scaffold of claim 30, wherein the bioresorbable polymeric fibers of the scaffold are made from polymers or copolymers formed from monomers selected from the group consisting of lactide, glycolide, dioxanone, and caprolactone.

43. The scaffold of claim 42, wherein the bioresorbable polymeric fibers of the scaffold are made from a copolymer having a ratio of monomers of about 95:

5 lactide and glycolide.

44. The scaffold of claim 30, wherein the scaffold comprises a ligament graft.

45. The scaffold of claim 44, wherein the scaffold comprises a cruciate ligament graft.

46. The scaffold of claim 36, wherein the scaffold further comprises at least one additional biological component applied thereto.

47. The scaffold of claim 46, wherein the at least one additional biological component comprises heterologous or autologous growth factors, proteins, matrix proteins, peptides, antibodies, antibiotics, anti-inflammatories, chemotactic agents, cell attachment mediators, biologically active ligands, integrin binding sequence, enzymes, cytokines, glycosaminoglycans, viruses, virus particles, nucleic acids, analgesics, cells, platelets, and combinations thereof.