Cancellous Bone Implant for Cartilage Repair

• US 20090149893A1
• Filed: 12/04/2008
• Published: 06/11/2009
• Est. Priority Date: 12/05/2007
• Status: Abandoned Application

• Current Assignee: Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: Semler, Eric J., Truncale, Katherine G., Callahan, Alex B., Shikhanovich, Roman
• Application Number:
  US12/328,306
• Publication Number:
  US 20090149893A1
• Time in Patent Office: Days
• US Class Current: 606/86.R
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3859 Femoral components
• 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 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30227 arched, domed or vaulted
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2002/30354 Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30759 Mosaicplasty, i.e. using a plurality of individual cartilage plugs for filling a substantial cartilage defect
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30789 : perpendicular with respect to each other
• CPC Class Codes: A61F 2002/30795 : Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/30932 : for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2002/3096 : trimmed or cut to a customised size
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4646 : Devices for cleaning bone graft
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2300/25 : Peptides having up to 20 amino acids in a defined sequence
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3654 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3804 : characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3852 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

The invention is directed toward a cartilage repair assembly comprising a shaped allograft construct comprising a cylindrical mineralized cancellous bone base member and a demineralized cancellous bone cap member having a cylindrical top portion and a stem extending from the top portion mounted to the bone base member. The base member has a central bore and a transverse bore which intersect the central bore and the cap member stem has a through going bore which is aligned with the base member transverse bore when the stem is mounted in the central bore to receive a pin member. Milled cartilage particles having a size ranging from 10 to 212 microns are mixed with a biocompatible carrier and a cartilage growth factor, with the mixture being infused in the cap member to generate cartilage growth.

Claims

1. A sterile cartilage repair construct derived from cancellous bone for repair of a defect in articular cartilage comprising a base member of mineralized cancellous bone, a cap member mounted to said base member, means to secure said cap member to said bone member, said cap member being constructed of demineralized cancellous bone, treated to be nonosteoinductive and infused with a composition comprising cartilage particles, a biocompatible carrier and at least one growth factor or bioactive peptide.

2. A sterile cartilage repair construct as claimed in claim 1 wherein said bioactive peptide is taken from a group of bioactive peptides consisting of Nell-1 and TP508.

3. A sterile cartilage repair construct as claimed in claim 1 wherein said base member has a cylindrical shape with a central bore defined therein and a transverse bore intersecting said central bore and said cap member has a cylindrical section and a stem extending from said cylindrical section, said stem defining a through going bore which can be aligned with said base member transverse bore when said stem is mounted in said central bore.

4. A sterile cartilage repair construct as claimed in claim 1 wherein said cap member is constructed of allograft bone.

5. A sterile cartilage repair construct as claimed in claim 1 wherein at least one of said cap member and said base member is constructed of xenograft cancellous bone.

6. A sterile cartilage repair construct as claimed in claim 1 wherein cartilage particles have a size less than 212 microns and form 20-40% w/w of the composition.

7. A sterile cartilage repair construct as claimed in claim 1 wherein cartilage particles have a size ranging from about 10 to about 212 microns.

8. A sterile cartilage repair construct as claimed in claim 1 wherein said cartilage particles are allograft cartilage.

9. A sterile cartilage repair construct as claimed in claim 1 wherein said cartilage particles are autograft cartilage.

10. A sterile cartilage repair construct as claimed in claim 1 wherein said cartilage particles are xenograft cartilage.

11. A sterile cartilage repair construct as claimed in claim 1 wherein said growth factor is FGF-2v.

12. A sterile cartilage repair construct as claimed in claim 1 wherein at least one of said construct members contains one or more of growth factors and variants taken from a group consisting of FGF-2, FGF-5, FGF-7, FGF-9, FGF-11, FGF-21, IGF-1, TGF-β

, BMP-2, BMP-4, BMP-7, PDGF, VEGF.

13. A sterile cartilage repair construct as claimed in claim 1 wherein at least one of said construct members contains one or more additives taken from a group consisting of human allogenic or autologous chondrocytes, human allogenic or autologous bone marrow cells and stem cells.

14. A sterile cartilage repair construct as claimed in claim 1 wherein at least one of said construct members contains one or more additives taken from a group consisting of insulin, insulin-like growth factor-1, transforming growth factor-B, interleukin-1 receptor antagonist, hepatocyte growth factor, platelet-derived growth factor, Indian hedgehog and parathyroid hormone-related peptide, bioactive glue, viral vectors for growth factor or DNA delivery, nanoparticles, or platelet-rich plasma.

15. A sterile cartilage repair construct as claimed in claim 1 securing means is at least one pin mounted in said cap member and said base member.

16. A sterile cartilage repair construct as claimed in claim 15 wherein said pin is constructed from a group of materials consisting of mineralized cancellous bone, partially demineralized cortical bone, substantially demineralized cortical bone, cortical bone, ceramic, stainless steel, and polymer.

17. A sterile cartilage repair construct as claimed in claim 16 wherein said pin means is a plurality of cylindrical members.

18. A sterile cartilage repair construct comprising a base member of mineralized cancellous bone, a cap member mounted to said base member, said cap member being constructed of demineralized cancellous bone, and infused with a composition comprising cartilage particles, a biocompatible carrier and a chondrogenic growth factor, said base member has a cylindrical shape with a central bore defined therein and a transverse bore intersecting said central bore, said cap member has a cylindrical section with a stem extending from said cylindrical section, said stem defining a through-going bore which can be aligned with said base member transverse bore when said stem is mounted in said central bore and pin means mounted in said stem bore and said base member transverse bore.

19. A sterile cartilage repair construct comprising a base member of mineralized allograft cancellous bone, a cap member mounted to said base member, said cap member being constructed of demineralized allograft cancellous bone, treated to be non-osteoinductive and infused with a composition comprising allograft cartilage particles having a size ranging from about 10 to about 212 microns, a biocompatible carrier and a chondrogenic growth factor, said base member has a cylindrical shape with a central bore defined therein and a transverse bore intersecting said central bore and said cap member has a cylindrical section with a planar bottom surface and a stem extending from said cylindrical section, said stem defining a through going bore which can be aligned with said base member transverse bore when said stem is mounted in said central bore and a pin mounted through the aligned bores in said base member and said cap member.

20. A sterile cartilage repair construct as claimed in claim 19 wherein said carrier is taken from a group consisting of sterile water, phosphate buffered saline, sodium hyaluronate solution, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, Dextran, carboxymethylcellulose (CMC), hydroxypropyl methylcellulose.

21. A sterile cartilage repair construct as claimed in claim 19 wherein said allograft cartilage particles are taken from a group consisting of hyaline cartilage, fibrous cartilage and a combination of hyaline and fibrous cartilage.

22. A sterile cartilage repair construct as claimed in claim 19 wherein said fibroblast growth factor FGF-2v is present in an amount of 10-5000 micrograms per cm³.

23. A sterile cartilage repair construct comprising a base member of mineralized allograft cancellous bone, a cap member mounted to said base member, said cap member being constructed of demineralized allograft cancellous bone, treated to be non-osteoinductive and infused with a composition comprising allograft cartilage particles, a biocompatible carrier and a growth factor, said cap member having a cylindrical shape with a central bore defined therein and a transverse bore intersecting said central bore, said base member defining a cylindrical section with a planar bottom surface and a stem extending from said cylindrical section, said stem defining a through going bore which can be aligned with said cap member transverse bore when said base member stem is mounted in said cap member central bore and a pin means mounted through the aligned bores in said base member and said cap member.

24. A process for constructing a sterile cartilage repair construct comprising the steps of:

a. milling a mineralized cancellous bone into a cylindrically shaped base member;

b. demineralizing a cap member adapted to be mounted to the base member;

c. treating the cap member to be non-osteoinductive;

d. mounting the cap member to the base member; and

e. infusing cartilage particles and at least one cartilage growth factor carried in a biocompatible carrier into the cap member.

25. A process as claimed in claim 24 wherein the said cartilage growth factor is FGF-2v.