CA2357980A1 - Malleable paste with allograft bone reinforcement for filling bone defects - Google Patents

Malleable paste with allograft bone reinforcement for filling bone defects Download PDF

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Publication number
CA2357980A1
CA2357980A1 CA002357980A CA2357980A CA2357980A1 CA 2357980 A1 CA2357980 A1 CA 2357980A1 CA 002357980 A CA002357980 A CA 002357980A CA 2357980 A CA2357980 A CA 2357980A CA 2357980 A1 CA2357980 A1 CA 2357980A1
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CA
Canada
Prior art keywords
bone
composition
ranging
sterile malleable
rods
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002357980A
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French (fr)
Other versions
CA2357980C (en
Inventor
Arthur A. Gertzman
Moon Hae Sunwoo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Musculoskeletal Transplant Foundation
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Musculoskeletal Transplant Foundation
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Publication of CA2357980A1 publication Critical patent/CA2357980A1/en
Application granted granted Critical
Publication of CA2357980C publication Critical patent/CA2357980C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • A—HUMAN NECESSITIES
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    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
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    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0047—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L24/0073—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix
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    • A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/005—Ingredients of undetermined constitution or reaction products thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891—Plurality of protrusions
    • A61F2002/30892—Plurality of protrusions parallel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891—Plurality of protrusions
    • A61F2002/30894—Plurality of protrusions inclined obliquely with respect to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0082—Three-dimensional shapes parallelepipedal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

The invention is directed toward a sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 750 microns and surface demineralized cortical bone rods having a diameter ranging from 1.0mm to 5.00mm or larger bone chips.
The surface demineralized cortical bone rods have diameter to length ratio ranging from 1:2 to 1:20.
The demineralized bone powder range from about 25 to about 30% of the weight of the composition and the cortical bone rods range from 5% to about 10% of the weight of the composition with the carrier being selected from the high molecular weight hydrogel in aqueous solution having a high molecular weight over 700,000 Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution.

Claims (51)

1. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic or osteoconductive bone powder with a particle size ranging from about 250 to about 750 microns and osteogenic bone chips of a larger size ranging from 0.1 to 10 mm in a carrier, the demineralized bone powder ranging from about 15% to about 35% of the weight of the composition and the osteogenic bone chips ranging from 5%
to about 20% of the weight of the composition, the Garner being selected from a aqueous sodium based phosphate buffered solution and a hydrogel consisting of a mucopolysaccharide, said mucopolysaccharide having a high molecular weight ranging from seven hundred thousand to three million Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution, said composition having a pH ranging from about 7.2 to about 7.4.
2. A sterile malleable bone composition as claimed in claim 1 wherein said composition includes bone morphogenic proteins in excess of the amount naturally occurring in allogeneic bone.
3. A sterile malleable bone composition as claimed in claim 1 wherein said phosphate includes two phosphate ions HPO4 -2 and H2PO4 -1.
4. A sterile malleable bone composition as claimed in claim 1 wherein said composition has an isotonic state of about 300 mOsmol/Kg.
5. A sterile malleable bone composition as claimed in claim 1 including the addition of a calcium salt to the carrier.
6. A sterile malleable bone composition as claimed in claim 1 wherein the balance of the carrier formulation contains a sodium phosphate buffer and has a pH of about
7.2.
7. A sterile malleable bone composition as claimed in claim 1 wherein said bone powder is cortical allograft bone powder.
8. A sterile malleable bone composition as claimed in claim 1 wherein said bone powder is cortical-cancellous allograft bone powder.
9. A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are cortical allograft bone chips.
10. A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are cortical-cancellous allograft bone chips.
11. A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are mineralized allograft bone chips.
12. A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are demineralized allograft bone chips.
13. A sterile malleable bone composition as claimed in claim 1 including antimicrobial and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin.
14. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel is sodium hyaluronate.
15. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel is chitosan.
16. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel is carboxy-methyl-cellulose.
17. A sterile malleable bone composition as claimed in claim 1 wherein said composition has a pH ranging from 6.8 to 7.4.
18. A sterile malleable bone composition as claimed in claim 1 wherein the aqueous solution includes an ionic salt based phosphate buffer.
19. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel has a molecular weight in excess of 700,000 Daltons.
20. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel has a molecular weight in excess of 1,000,000 Daltons.
21. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel consists of the group of sodium hyaluronate, chitosan and carboxy-methyl-cellulose.
22. A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel substantially maintains its viscosity from 22-37 degrees C.
23. A sterile malleable bone composition as claimed in claim 1 wherein said aqueous solution is saline.
24. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 1000 microns and cortical bone rods having a length ranging from 1 mm to about 10mm and a thickness to length ratio ranging of about 1:2 to 1:20, the demineralized bone powder ranging from about 15 to about 30% of the weight of the composition and the cortical bone rods ranging from 5% to about 20% of the weight of the composition, said carrier comprising a hydrogel selected from a group consisting of sodium hyaluronate, chitosan and carboxy-methyl-cellulose in saline phosphate buffer solution, said hydrogel having a high molecular weight ranging from about seven hundred thousand to about three million Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution, said composition having a substantially neutral osmolality.
25. A sterile malleable bone composition as claimed in claim 24 wherein said composition mixture includes bone morphogenic proteins in excess of the amount naturally occurring in allogeneic bone.
26. A sterile malleable bone composition as claimed in claim 24 wherein said phosphate buffer includes two phosphate ions HPO4 -2 and H2PO4 -1.
27. A sterile malleable bone composition as claimed in claim 24 wherein said composition has an isotonic state of about 300 mOsmol/Kg.
28. A sterile malleable bone composition as claimed in claim 24 wherein said bone rods are orientated in substantially one direction in said composition.
29. A sterile malleable bone composition as claimed in claim 24 including antimicrobial and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin.
30. A sterile malleable bone composition as claimed in claim 24 wherein said hydrogel has a molecular weight in excess of one million Daltons.
31. A sterile malleable bone composition as claimed in claim 24 wherein said hydrogel consists of the group of sodium hyaluronate, chitosan and carboxy-methyl-cellulose.
32. A sterile malleable bone composition as claimed in claim 24 wherein said bone rods have a diameter ranging from 0.4mm to about 2.0mm
33. A sterile malleable bone composition as claimed in claim 24 wherein said cortical bone rods are partially demineralized.
34. A sterile malleable bone composition as claimed in claim 33 wherein said bone rods have a diameter ranging from 3.0mm to about 5.00mm.
35. A sterile malleable bone composition as claimed in claim 24 wherein said cortical bone rods are fully demineralized and flexible.
36. A sterile malleable bone composition as claimed in claim 24 wherein said cortical bone rods are randomly orientated in said composition.
37. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 750 microns and surface demineralized cortical bone rods having a diameter ranging from 1.0mm to 5.00mm with a diameter to length ratio ranging from 1:2 to 1:20, the demineralized bone powder ranging from about 25 to about 30% of the weight of the composition and the cortical bone rods ranging from 5% to about 10% of the weight of the composition, said carrier comprising a high molecular weight hydrogel mucosaccharide in aqueous phosphate buffered solution, said mucosaccharide having a high molecular weight over 700,000 Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution.
38. A sterile malleable bone composition as claimed in claim 37 wherein said cortical bone rods are randomly oriented in said composition.
39. A sterile malleable bone composition as claimed in claim 37 wherein said cortical bone rods are oriented in substantially one direction in said composition.
40. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 1000 microns and mineralized cortical bone rods having a diameter ranging from 0.4 to about 2.0 mm and a diameter to length ratio of about 2- to about 6, the demineralized bone powder ranging from about 25 to about 35% of the weight of the composition and the mineralized cortical rods ranging from 5% to about 25% of the weight of the composition, said carrier comprising a hydrogel selected from a group consisting of sodium hyaluronate, chitosan and carboxy-methyl-cellulose in a buffered phosphate saline solution, said hydrogel having a high molecular weight of at least 1.0 x 106 Daltons and ranging from about 1.0% to about 5.0% by weight of the carrier solution.
41. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing mixture of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized cortical allograft bone chips ranging from 1.0mm to 10.00 mm in size and cortical bone rods in a hyaluronic acid saline phosphate buffer carrier, the hyaluronic acid component ranging from above 2.0% to about 5% of the carrier solution and having a molecular weight of at least 6 Daltons, the total bone content of the bone powder, bone chips and bone rods in the carrier ranging in weight from about 30% to about 50% total weight of the composition.
42. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone chips ranging from 0.1mm - 10mm in a high molecular weight sodium hyaluronate and saline carrier with a phosphate buffer, the bone content of the composition ranging from about 25% to about 45% by weight and the high molecular weight sodium hyaluronate component ranges from about 2%
to about 5% of the carrier and has a molecular weight greater than one million Daltons.
43. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone chips ranging from 1 - 10mm in size in a carrier solution, said carrier solution comprising a high molecular weight chitosan having a molecular weight over 1.0 x 10 5 Daltons in an aqueous buffered phosphate with the bone content of the putty composition ranging from about 30%
to about 35% and the chitosan component ranging from 2 to 5% of the carrier solution and said composition having a substantially neutral osmolality.
44. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing demineralized lyophilized allografr bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone cortical bone rods having a diameter to length ratio ranging from 1:2 - 1:20mm in length in a carrier, said carrier comprising a high molecular weight chitosan having a molecular weight over 1.0 x 10 6 Daltons in a water phosphate buffered solution with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component ranging from 2 to 5%
of the carrier solution.
45. A sterile malleable bone putty as claimed in claim 44 wherein said cortical bone rods are mineralized.
46. A sterile malleable bone putty as claimed in claim 44 wherein said cortical bone rods are partially demineralized.
47. A sterile malleable bone putty as claimed in claim 44 wherein said cortical bone rods are fully demineralized.
48. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone cortical bone rods having a diameter to length ratio ranging from 1:2 - 1:20mm in length in a high molecular weight carboxy-methyl-cellulose phosphate buffered water Garner solution with the bone content of the putty composition ranging from about 30% to about 35% and the carboxy-methyl-cellulose component ranging from 2 to 5% of the carrier solution.
49. A sterile malleable bone putty as claimed in claim 48 wherein said cortical bone rods are mineralized.
50. A sterile malleable bone putty as claimed in claim 48 wherein said cortical bone rods are partially demineralized.
51. A sterile malleable bone putty as claimed in claim 48 wherein said cortical bone rods are fully demineralized.
CA002357980A 2000-10-03 2001-10-02 Malleable paste with allograft bone reinforcement for filling bone defects Expired - Lifetime CA2357980C (en)

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US09/677,891 US6458375B1 (en) 1998-02-27 2000-10-03 Malleable paste with allograft bone reinforcement for filling bone defects

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