Scaffold for connective tissue repair

• US 8,226,715 B2
• Filed: 06/30/2003
• Issued: 07/24/2012
• Est. Priority Date: 06/30/2003
• Status: Expired due to Term

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Hwang, Julia, Hammer, Joseph, Schwartz, Herb, Malaviya, Prasanna
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Miller, Cheryl
• Application Number:
  US10/610,362
• Publication Number:
  US 20040267362A1
• Time in Patent Office: 3,312 Days
• Field of Search: 623/11.11, 623 1311- 132, 623 15- 154, 623/14.12, 623 2372- 2376, 606/151, 606/154
• US Class Current: 623/13.14
• 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 the longitudinal axis of the scaffold, wherein the substantially transverse fibers interlock the longitudinal fibers in two directions in a three-dimensional weave so as to form a three-dimensional woven structure; 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, wherein the central segment does not include any fibers oriented in a direction substantially transverse 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 woven structure 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.

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

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

7. 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.

8. The scaffold of claim 1, wherein the scaffold further comprises an adhesion agent.

9. The scaffold of claim 8, 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.

10. The scaffold of claim 8, 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.

11. 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.

12. The scaffold of claim 11, 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.

13. The scaffold of claim 11, 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.

14. The scaffold of claim 1, wherein the bioresorbable 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.

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

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

17. The scaffold of claim 1, wherein the scaffold further comprises at least one additional biological component applied thereto.

18. The scaffold of claim 17, 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.

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

20. A kit to assist in preparing a connective tissue scaffold, comprising:

the tissue scaffold of claim 1;

a container configured to hold one or more connective tissue scaffolds;

a harvesting tool configured to collect one or more living tissue samples; and

one or more reagents configured to sustain viability of one or more living tissue samples.

21. The kit of claim 20, further comprising:

a processing tool configured to divide one or more living tissue samples into minced tissue particles; and

a delivery device configured to transfer one or more connective tissue scaffolds from the container to a desired location.

22. The kit of claim 21, wherein the processing tool further comprises one or more scalpels.

23. The kit of claim 21, wherein the delivery device comprises an injection mechanism.

24. The kit of claim 20, wherein the harvesting tool is further configured to process one or more living tissue samples into finely divided tissue particles, the kit further comprising:

a delivery device configured to transfer one or more connective tissue scaffolds from the container to a desired location.

25. The kit of claim 20, wherein the one or more reagents is a physiological solution selected from the group consisting of:

saline, phosphate buffering solution, Hank'"'"'s balanced salt, standard cell culture medium, Dulbecco'"'"'s modified Eagle'"'"'s medium, ascorbic acid, HEPES, nonessential amino acid, L-proline, fetal bovine serum, autologous serum, and combinations thereof.

26. The kit of claim 20, further comprising a cell spreader configured to spread tissue on the scaffold.

27. The kit of claim 20, further comprising an adhesive agent configured to adhere tissue particles to the scaffold.

28. 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 at least one minced tissue particle and populate the scaffold.

29. The scaffold of claim 28, wherein the at least one minced tissue particle is a plurality of minced tissue particles.

30. The scaffold of claim 28, wherein a particle size of the at least one minced tissue particle is about 1 mm³.

31. The scaffold of claim 28, wherein a concentration of the at least one minced tissue particle is in the range of about 1 to 20 mg/cm².

32. The scaffold of claim 28, wherein the at least one minced tissue particle comprises a bone tissue type.

33. The scaffold of claim 32, wherein the central segment is free of tissue particles of a bone tissue type.

34. The scaffold of claim 32, wherein the bone tissue type is placed in the first and second anchoring segments of the scaffold.

35. The scaffold of claim 28, wherein the at least one minced tissue particle comprises a bone-free tissue type.

36. The scaffold of claim 35, wherein the tissue is minced as the tissue is being collected.

37. The scaffold of claim 35, wherein the bone-free tissue type is 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 28, wherein the at least one minced tissue particle comprises autogeneic tissue.

39. The scaffold of claim 1, wherein the scaffold further includes a sleeve comprised of a material, the material being biocompatible and bioresorbable.

40. The scaffold of claim 39, wherein the sleeve covers at least a portion of the first and second anchoring segments and the central segment.

41. The scaffold of claim 39, wherein the bioresorbable material is a biological material.

42. The scaffold of claim 39, wherein the bioresorbable material is small intestine submucosa.

43. The scaffold of claim 39, wherein the sleeve is formed over the first and second anchoring segments and the central segment.

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