Scaffold for connective tissue repair

• US 9,211,362 B2
• Filed: 06/08/2012
• Issued: 12/15/2015
• Est. Priority Date: 06/30/2003
• Status: Active Grant

• Current Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Original Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Inventors: Hwang, Julia, Hammer, Joseph, Schwartz, Herb, Malaviya, Prasanna
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US13/491,985
• Publication Number:
  US 20120253464A1
• Time in Patent Office: 1,285 Days
• Field of Search: 623 1311- 132, 623/23.75, 606/154
• US Class Current: 1/1
• 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 eyelets located at opposed ends of the scaffold along a longitudinal axis of the scaffold that extends along a longitudinal length thereof, the eyelets each being formed of a plurality of bioresorbable eyelet region polymeric fibers and defining an open area, and central axes extending through each of the open areas of the first and second anchoring eyelets such that the central axes are disposed substantially perpendicular with respect to the longitudinal axis of the scaffold, each open area being substantially larger than any adjacent void space between the plurality of bioresorbable eyelet region polymeric fibers;

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

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

wherein an overall fiber density of the central segment is lower than an overall fiber density of the binding regions,

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, and

wherein the bioresorbable material is formed over the first and second anchoring eyelets, the first and second binding regions, and the central segment, and the bioresorbable material is not in a form of a coating.

2. The scaffold of claim 1, wherein the fibers of the first and second binding regions are joined in a weave pattern.

3. The scaffold of claim 1, wherein the bioresorbable material is a biological material.

4. 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.

5. The scaffold of claim 4, 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.

6. The scaffold of claim 4, wherein the at least one minced tissue particle comprises a bone tissue type that is placed in the first and second binding regions of the scaffold.

7. The scaffold of claim 4, wherein the scaffold further comprises an adhesion agent.

8. The scaffold of claim 7, 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.

9. The scaffold of claim 7, 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.

10. The scaffold of claim 4, wherein the scaffold further comprises at least one additional biological component applied thereto.

11. The scaffold of claim 10, 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.

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

13. The scaffold of claim 12, wherein the bioresorbable polymeric fibers are made from a copolymer having a ratio of monomers of about 95:

5 lactide and glycolide.

14. The scaffold of claim 1, wherein the scaffold is configured for use as a substitute for a ligament graft.

15. The scaffold of claim 14, wherein the scaffold is configured for use as a substitute for a cruciate ligament graft.

16. The scaffold of claim 1, 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.

17. A connective tissue scaffold, comprising:

opposed first and second anchoring eyelets located at opposed ends of the scaffold along a longitudinal axis of the scaffold that extends along a longitudinal length thereof, the eyelets each being formed of a plurality of bioresorbable eyelet region polymeric fibers and defining an open area, and central axes extending through each of the open areas of the first and second anchoring eyelets such that the central axes are disposed substantially perpendicular with respect to the longitudinal axis of the scaffold, each open area being substantially larger than any adjacent void space between the plurality of bioresorbable eyelet region polymeric fibers;

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

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

wherein an overall fiber density of the central segment is lower than an overall fiber density of the binding regions; and

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,

wherein the bioresorbable material is a biological material,

wherein the bioresorbable material is small intestine submucosa, and

wherein the bioresorbable material is formed over the first and second anchoring eyelets, the first and second binding regions, and the central segment, and the bioresorbable material is not in a form of a coating.

18. The scaffold of claim 17, wherein the fibers of the first and second binding regions are joined in a weave pattern.

19. The scaffold of claim 17, 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.